Title 21

PART 876

Part 876 - Gastroenterology-urology Devices

PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:48 FR 53023, Nov. 23, 1983, unless otherwise noted.

21:8.0.1.1.25.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.25.1.1.1SECTION 876.1
   876.1 Scope.
21:8.0.1.1.25.1.1.2SECTION 876.3
   876.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.25.1.1.3SECTION 876.9
   876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.25.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.25.2.1.1SECTION 876.1075
   876.1075 Gastroenterology-urology biopsy instrument.
21:8.0.1.1.25.2.1.2SECTION 876.1080
   876.1080 Gastroenterology-urology accessories to a biopsy instrument.
21:8.0.1.1.25.2.1.3SECTION 876.1300
   876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
21:8.0.1.1.25.2.1.4SECTION 876.1330
   876.1330 Colon capsule endoscopy system.
21:8.0.1.1.25.2.1.5SECTION 876.1400
   876.1400 Stomach pH electrode.
21:8.0.1.1.25.2.1.6SECTION 876.1500
   876.1500 Endoscope and accessories.
21:8.0.1.1.25.2.1.7SECTION 876.1620
   876.1620 Urodynamics measurement system.
21:8.0.1.1.25.2.1.8SECTION 876.1725
   876.1725 Gastrointestinal motility monitoring system.
21:8.0.1.1.25.2.1.9SECTION 876.1735
   876.1735 Electrogastrography system.
21:8.0.1.1.25.2.1.10SECTION 876.1800
   876.1800 Urine flow or volume measuring system.
21:8.0.1.1.25.3SUBPART C
Subpart C - Monitoring Devices
21:8.0.1.1.25.3.1.1SECTION 876.2040
   876.2040 Enuresis alarm.
21:8.0.1.1.25.3.1.2SECTION 876.2050
   876.2050 Prostate lesion documentation system.
21:8.0.1.1.25.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.25.4.1.1SECTION 876.3350
   876.3350 Penile inflatable implant.
21:8.0.1.1.25.4.1.2SECTION 876.3500
   876.3500 Penile implant surgical accessories.
21:8.0.1.1.25.4.1.3SECTION 876.3630
   876.3630 Penile rigidity implant.
21:8.0.1.1.25.4.1.4SECTION 876.3750
   876.3750 Testicular prosthesis.
21:8.0.1.1.25.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.25.5.1.1SECTION 876.4020
   876.4020 Fiberoptic light ureteral catheter.
21:8.0.1.1.25.5.1.2SECTION 876.4270
   876.4270 Colostomy rod.
21:8.0.1.1.25.5.1.3SECTION 876.4300
   876.4300 Endoscopic electrosurgical unit and accessories.
21:8.0.1.1.25.5.1.4SECTION 876.4310
   876.4310 Endoscopic electrosurgical clip cutting system.
21:8.0.1.1.25.5.1.5SECTION 876.4340
   876.4340 High intensity ultrasound system for prostate tissue ablation.
21:8.0.1.1.25.5.1.6SECTION 876.4350
   876.4350 Fluid jet system for prostate tissue removal.
21:8.0.1.1.25.5.1.7SECTION 876.4370
   876.4370 Gastroenterology-urology evacuator.
21:8.0.1.1.25.5.1.8SECTION 876.4400
   876.4400 Hemorrhoidal ligator.
21:8.0.1.1.25.5.1.9SECTION 876.4480
   876.4480 Electrohydraulic lithotriptor.
21:8.0.1.1.25.5.1.10SECTION 876.4500
   876.4500 Mechanical lithotriptor.
21:8.0.1.1.25.5.1.11SECTION 876.4530
   876.4530 Gastroenterology-urology fiberoptic retractor.
21:8.0.1.1.25.5.1.12SECTION 876.4560
   876.4560 Ribdam.
21:8.0.1.1.25.5.1.13SECTION 876.4590
   876.4590 Interlocking urethral sound.
21:8.0.1.1.25.5.1.14SECTION 876.4620
   876.4620 Ureteral stent.
21:8.0.1.1.25.5.1.15SECTION 876.4630
   876.4630 Ureteral stent accessories.
21:8.0.1.1.25.5.1.16SECTION 876.4650
   876.4650 Water jet renal stone dislodger system.
21:8.0.1.1.25.5.1.17SECTION 876.4680
   876.4680 Ureteral stone dislodger.
21:8.0.1.1.25.5.1.18SECTION 876.4730
   876.4730 Manual gastroenterology-urology surgical instrument and accessories.
21:8.0.1.1.25.5.1.19SECTION 876.4770
   876.4770 Urethrotome.
21:8.0.1.1.25.5.1.20SECTION 876.4890
   876.4890 Urological table and accessories.
21:8.0.1.1.25.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.25.6.1.1SECTION 876.5010
   876.5010 Biliary catheter and accessories.
21:8.0.1.1.25.6.1.2SECTION 876.5011
   876.5011 Metallic biliary stent system for benign strictures.
21:8.0.1.1.25.6.1.3SECTION 876.5012
   876.5012 Biliary stent, drain, and dilator accessories.
21:8.0.1.1.25.6.1.4SECTION 876.5015
   876.5015 Pancreatic drainage stent and delivery system.
21:8.0.1.1.25.6.1.5SECTION 876.5020
   876.5020 External penile rigidity devices.
21:8.0.1.1.25.6.1.6SECTION 876.5025
   876.5025 Vibrator for climax control of premature ejaculation.
21:8.0.1.1.25.6.1.7SECTION 876.5030
   876.5030 Continent ileostomy catheter.
21:8.0.1.1.25.6.1.8SECTION 876.5090
   876.5090 Suprapubic urological catheter and accessories.
21:8.0.1.1.25.6.1.9SECTION 876.5100
   876.5100 Suprapubic catheter accessories.
21:8.0.1.1.25.6.1.10SECTION 876.5130
   876.5130 Urological catheter and accessories.
21:8.0.1.1.25.6.1.11SECTION 876.5140
   876.5140 Urethral insert with pump for bladder drainage.
21:8.0.1.1.25.6.1.12SECTION 876.5160
   876.5160 Urological clamp.
21:8.0.1.1.25.6.1.13SECTION 876.5210
   876.5210 Enema kit.
21:8.0.1.1.25.6.1.14SECTION 876.5220
   876.5220 Colonic irrigation system.
21:8.0.1.1.25.6.1.15SECTION 876.5250
   876.5250 Urine collector and accessories.
21:8.0.1.1.25.6.1.16SECTION 876.5270
   876.5270 Implanted electrical urinary continence device.
21:8.0.1.1.25.6.1.17SECTION 876.5280
   876.5280 Implanted mechanical/hydraulic urinary continence device.
21:8.0.1.1.25.6.1.18SECTION 876.5290
   876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories.
21:8.0.1.1.25.6.1.19SECTION 876.5310
   876.5310 Nonimplanted, peripheral electrical continence device.
21:8.0.1.1.25.6.1.20SECTION 876.5320
   876.5320 Nonimplanted electrical continence device.
21:8.0.1.1.25.6.1.21SECTION 876.5365
   876.5365 Esophageal dilator.
21:8.0.1.1.25.6.1.22SECTION 876.5450
   876.5450 Rectal dilator.
21:8.0.1.1.25.6.1.23SECTION 876.5470
   876.5470 Ureteral dilator.
21:8.0.1.1.25.6.1.24SECTION 876.5520
   876.5520 Urethral dilator.
21:8.0.1.1.25.6.1.25SECTION 876.5530
   876.5530 Implantable transprostatic tissue retractor system.
21:8.0.1.1.25.6.1.26SECTION 876.5540
   876.5540 Blood access device and accessories.
21:8.0.1.1.25.6.1.27SECTION 876.5550
   876.5550 Prostatic artery embolization device.
21:8.0.1.1.25.6.1.28SECTION 876.5600
   876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
21:8.0.1.1.25.6.1.29SECTION 876.5630
   876.5630 Peritoneal dialysis system and accessories.
21:8.0.1.1.25.6.1.30SECTION 876.5665
   876.5665 Water purification system for hemodialysis.
21:8.0.1.1.25.6.1.31SECTION 876.5820
   876.5820 Hemodialysis system and accessories.
21:8.0.1.1.25.6.1.32SECTION 876.5830
   876.5830 Hemodialyzer with disposable insert (Kiil type).
21:8.0.1.1.25.6.1.33SECTION 876.5860
   876.5860 High permeability hemodialysis system.
21:8.0.1.1.25.6.1.34SECTION 876.5870
   876.5870 Sorbent hemoperfusion system.
21:8.0.1.1.25.6.1.35SECTION 876.5880
   876.5880 Isolated kidney perfusion and transport system and accessories.
21:8.0.1.1.25.6.1.36SECTION 876.5885
   876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.
21:8.0.1.1.25.6.1.37SECTION 876.5895
   876.5895 Ostomy irrigator.
21:8.0.1.1.25.6.1.38SECTION 876.5900
   876.5900 Ostomy pouch and accessories.
21:8.0.1.1.25.6.1.39SECTION 876.5920
   876.5920 Protective garment for incontinence.
21:8.0.1.1.25.6.1.40SECTION 876.5930
   876.5930 Rectal control system.
21:8.0.1.1.25.6.1.41SECTION 876.5955
   876.5955 Peritoneo-venous shunt.
21:8.0.1.1.25.6.1.42SECTION 876.5970
   876.5970 Hernia support.
21:8.0.1.1.25.6.1.43SECTION 876.5980
   876.5980 Gastrointestinal tube and accessories.
21:8.0.1.1.25.6.1.44SECTION 876.5981
   876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.
21:8.0.1.1.25.6.1.45SECTION 876.5985
   876.5985 Enzyme packed cartridge.
21:8.0.1.1.25.6.1.46SECTION 876.5990
   876.5990 Extracorporeal shock wave lithotripter.