TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
Subpart A - General Provisions
§ 876.1 - Scope.
§ 876.3 - Effective dates of requirement for premarket approval.
§ 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B - Diagnostic Devices
§ 876.1050 - Endoscopic transhepatic venous access needle.
§ 876.1075 - Gastroenterology-urology biopsy instrument.
§ 876.1080 - Gastroenterology-urology accessories to a biopsy instrument.
§ 876.1300 - Ingestible telemetric gastrointestinal capsule imaging system.
§ 876.1310 - Magnetically maneuvered capsule endoscopy system.
§ 876.1330 - Colon capsule endoscopy system.
§ 876.1400 - Stomach pH electrode.
§ 876.1450 - Esophageal tissue characterization system.
§ 876.1500 - Endoscope and accessories.
§ 876.1520 - Gastrointestinal lesion software detection system.
§ 876.1620 - Urodynamics measurement system.
§ 876.1725 - Gastrointestinal motility monitoring system.
§ 876.1735 - Electrogastrography system.
§ 876.1800 - Urine flow or volume measuring system.
Subpart C - Monitoring Devices
§ 876.2040 - Enuresis alarm.
§ 876.2050 - Prostate lesion documentation system.
§ 876.2100 - Pressure ulcer management tool.
Subpart D - Prosthetic Devices
§ 876.3350 - Penile inflatable implant.
§ 876.3500 - Penile implant surgical accessories.
§ 876.3630 - Penile rigidity implant.
§ 876.3750 - Testicular prosthesis.
Subpart E - Surgical Devices
§ 876.4020 - Fiberoptic light ureteral catheter.
§ 876.4270 - Colostomy rod.
§ 876.4300 - Endoscopic electrosurgical unit and accessories.
§ 876.4310 - Endoscopic electrosurgical clip cutting system.
§ 876.4340 - High intensity ultrasound system for prostate tissue ablation.
§ 876.4350 - Fluid jet system for prostate tissue removal.
§ 876.4370 - Gastroenterology-urology evacuator.
§ 876.4400 - Hemorrhoidal ligator.
§ 876.4480 - Electrohydraulic lithotriptor.
§ 876.4500 - Mechanical lithotriptor.
§ 876.4530 - Gastroenterology-urology fiberoptic retractor.
§ 876.4560 - Ribdam.
§ 876.4590 - Interlocking urethral sound.
§ 876.4620 - Ureteral stent.
§ 876.4630 - Ureteral stent accessories.
§ 876.4650 - Water jet renal stone dislodger system.
§ 876.4680 - Ureteral stone dislodger.
§ 876.4730 - Manual gastroenterology-urology surgical instrument and accessories.
§ 876.4770 - Urethrotome.
§ 876.4890 - Urological table and accessories.
Subpart F - Therapeutic Devices
§ 876.5010 - Biliary catheter and accessories.
§ 876.5011 - Metallic biliary stent system for benign strictures.
§ 876.5012 - Biliary stent, drain, and dilator accessories.
§ 876.5015 - Pancreatic drainage stent and delivery system.
§ 876.5020 - External penile rigidity devices.
§ 876.5025 - Vibrator for climax control of premature ejaculation.
§ 876.5026 - Non-implanted electrical stimulation device for management of premature ejaculation.
§ 876.5030 - Continent ileostomy catheter.
§ 876.5090 - Suprapubic urological catheter and accessories.
§ 876.5100 - Suprapubic catheter accessories.
§ 876.5130 - Urological catheter and accessories.
§ 876.5140 - Urethral insert with pump for bladder drainage.
§ 876.5160 - Urological clamp.
§ 876.5210 - Enema kit.
§ 876.5220 - Colonic irrigation system.
§ 876.5250 - Urine collector and accessories.
§ 876.5270 - Implanted electrical urinary continence device.
§ 876.5280 - Implanted mechanical/hydraulic urinary continence device.
§ 876.5290 - Implanted mechanical/hydraulic urinary continence device surgical accessories.
§ 876.5310 - Nonimplanted, peripheral electrical continence device.
§ 876.5320 - Nonimplanted electrical continence device.
§ 876.5330 - Transcutaneous electrical continence device.
§ 876.5340 - Nonimplanted nerve stimulator for functional abdominal pain relief.
§ 876.5365 - Esophageal dilator.
§ 876.5450 - Rectal dilator.
§ 876.5470 - Ureteral dilator.
§ 876.5520 - Urethral dilator.
§ 876.5530 - Implantable transprostatic tissue retractor system.
§ 876.5540 - Blood access device and accessories.
§ 876.5550 - Prostatic artery embolization device.
§ 876.5600 - Sorbent regenerated dialysate delivery system for hemodialysis.
§ 876.5630 - Peritoneal dialysis system and accessories.
§ 876.5665 - Water purification system for hemodialysis.
§ 876.5820 - Hemodialysis system and accessories.
§ 876.5830 - Hemodialyzer with disposable insert (Kiil type).
§ 876.5860 - High permeability hemodialysis system.
§ 876.5870 - Sorbent hemoperfusion system.
§ 876.5880 - Isolated kidney perfusion and transport system and accessories.
§ 876.5885 - Tissue culture media for human ex vivo tissue and cell culture processing applications.
§ 876.5895 - Ostomy irrigator.
§ 876.5900 - Ostomy pouch and accessories.
§ 876.5920 - Protective garment for incontinence.
§ 876.5930 - Rectal control system.
§ 876.5955 - Peritoneo-venous shunt.
§ 876.5960 - Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.
§ 876.5970 - Hernia support.
§ 876.5980 - Gastrointestinal tube and accessories.
§ 876.5981 - Oral removable palatal space occupying device for weight management and/or weight loss.
§ 876.5982 - Ingested, transient, space occupying device for weight management and/or weight loss.
§ 876.5985 - Enzyme packed cartridge.
§ 876.5990 - Extracorporeal shock wave lithotripter.
| 
