GroundRules
Browse Federal regulations
Read the original sections, or search by topic.
- 21 CFR 876.4400 · Hemorrhoidal ligator.
- 21 CFR 876.4410 · Endoscopic traction device.
- 21 CFR 876.4480 · Electrohydraulic lithotriptor.
- 21 CFR 876.4500 · Mechanical lithotriptor.
- 21 CFR 876.4530 · Gastroenterology-urology fiberoptic retractor.
- 21 CFR 876.4560 · Ribdam.
- 21 CFR 876.4590 · Interlocking urethral sound.
- 21 CFR 876.4620 · Ureteral stent.
- 21 CFR 876.4630 · Ureteral stent accessories.
- 21 CFR 876.4650 · Water jet renal stone dislodger system.
- 21 CFR 876.4680 · Ureteral stone dislodger.
- 21 CFR 876.4730 · Manual gastroenterology-urology surgical instrument and accessories.
- 21 CFR 876.4770 · Urethrotome.
- 21 CFR 876.4890 · Urological table and accessories.
- 21 CFR 876.5010 · Biliary catheter and accessories.
- 21 CFR 876.5011 · Metallic biliary stent system for benign strictures.
- 21 CFR 876.5012 · Biliary stent, drain, and dilator accessories.
- 21 CFR 876.5015 · Pancreatic drainage stent and delivery system.
- 21 CFR 876.5020 · External penile rigidity devices.
- 21 CFR 876.5021 · Non-medicated topical formulation for treatment of erectile dysfunction.
- 21 CFR 876.5025 · Vibrator for climax control of premature ejaculation.
- 21 CFR 876.5026 · Non-implanted electrical stimulation device for management of premature ejaculation.
- 21 CFR 876.5030 · Continent ileostomy catheter.
- 21 CFR 876.5090 · Suprapubic urological catheter and accessories.
- 21 CFR 876.5100 · Suprapubic catheter accessories.
- 21 CFR 876.5130 · Urological catheter and accessories.
- 21 CFR 876.5140 · Urethral insert with pump for bladder drainage.
- 21 CFR 876.5160 · Urological clamp.
- 21 CFR 876.5210 · Enema kit.
- 21 CFR 876.5220 · Colonic irrigation system.
- 21 CFR 876.5250 · Urine collector and accessories.
- 21 CFR 876.5270 · Implanted electrical urinary continence device.
- 21 CFR 876.5280 · Implanted mechanical/hydraulic urinary continence device.
- 21 CFR 876.5290 · Implanted mechanical/hydraulic urinary continence device surgical accessories.
- 21 CFR 876.5305 · Implanted tibial electrical urinary continence device.
- 21 CFR 876.5310 · Nonimplanted, peripheral electrical continence device.
- 21 CFR 876.5320 · Nonimplanted electrical continence device.
- 21 CFR 876.5330 · Transcutaneous electrical continence device.
- 21 CFR 876.5340 · Nonimplanted nerve stimulator for functional abdominal pain relief.
- 21 CFR 876.5360 · Laparoscopic gastrointestinal sizing tool.
- 21 CFR 876.5365 · Esophageal dilator.
- 21 CFR 876.5450 · Rectal dilator.
- 21 CFR 876.5470 · Ureteral dilator.
- 21 CFR 876.5510 · Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia.
- 21 CFR 876.5520 · Urethral dilator.
- 21 CFR 876.5530 · Implantable transprostatic tissue retractor system.
- 21 CFR 876.5540 · Blood access device and accessories.
- 21 CFR 876.5550 · Prostatic artery embolization device.
- 21 CFR 876.5600 · Sorbent regenerated dialysate delivery system for hemodialysis.
- 21 CFR 876.5630 · Peritoneal dialysis system and accessories.
- 21 CFR 876.5665 · Water purification system for hemodialysis.
- 21 CFR 876.5820 · Hemodialysis system and accessories.
- 21 CFR 876.5830 · Hemodialyzer with disposable insert (Kiil type).
- 21 CFR 876.5860 · High permeability hemodialysis system.
- 21 CFR 876.5861 · Pediatric continuous renal replacement therapy system.
- 21 CFR 876.5862 · Hemodialyzer with expanded solute removal profile.
- 21 CFR 876.5870 · Sorbent hemoperfusion system.
- 21 CFR 876.5880 · Isolated kidney perfusion and transport system and accessories.
- 21 CFR 876.5885 · Tissue culture media for human ex vivo tissue and cell culture processing applications.
- 21 CFR 876.5895 · Ostomy irrigator.
- 21 CFR 876.5900 · Ostomy pouch and accessories.
- 21 CFR 876.5920 · Protective garment for incontinence.
- 21 CFR 876.5930 · Rectal control system.
- 21 CFR 876.5940 · Orally ingested transient device for constipation.
- 21 CFR 876.5955 · Peritoneo-venous shunt.
- 21 CFR 876.5960 · Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.
- 21 CFR 876.5970 · Hernia support.
- 21 CFR 876.5980 · Gastrointestinal tube and accessories.
- 21 CFR 876.5981 · Oral removable palatal space occupying device for weight management and/or weight loss.
- 21 CFR 876.5982 · Ingested, transient, space occupying device for weight management and/or weight loss.
- 21 CFR 876.5983 · Endoscopic suturing device for altering gastric anatomy for weight loss.
- 21 CFR 876.5985 · Enzyme packed cartridge.
- 21 CFR 876.5990 · Extracorporeal shock wave lithotripter.
- 21 CFR 878.1 · Scope.
- 21 CFR 878.3 · Effective dates of requirement for premarket approval.
- 21 CFR 878.9 · Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- 21 CFR 878.1800 · Speculum and accessories.
- 21 CFR 878.1820 · Software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.
- 21 CFR 878.3250 · External facial fracture fixation appliance.
- 21 CFR 878.3300 · Surgical mesh.
- 21 CFR 878.3500 · Polytetrafluoroethylene with carbon fibers composite implant material.
- 21 CFR 878.3510 · Carbon dioxide gas controlled tissue expander.
- 21 CFR 878.3530 · Silicone inflatable breast prosthesis.
- 21 CFR 878.3540 · Silicone gel-filled breast prosthesis.
- 21 CFR 878.3550 · Chin prosthesis.
- 21 CFR 878.3590 · Ear prosthesis.
- 21 CFR 878.3610 · Esophageal prosthesis.
- 21 CFR 878.3680 · Nose prosthesis.
- 21 CFR 878.3720 · Tracheal prosthesis.
- 21 CFR 878.3750 · External prosthesis adhesive.
- 21 CFR 878.3800 · External aesthetic restoration prosthesis.
- 21 CFR 878.3900 · Inflatable extremity splint.
- 21 CFR 878.3910 · Noninflatable extremity splint.
- 21 CFR 878.3925 · Plastic surgery kit and accessories.
- 21 CFR 878.4010 · Tissue adhesive.
- 21 CFR 878.4011 · Tissue adhesive with adjunct wound closure device for topical approximation of skin.
- 21 CFR 878.4014 · Nonresorbable gauze/sponge for external use.
- 21 CFR 878.4015 · Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
- 21 CFR 878.4018 · Hydrophilic wound dressing.
- 21 CFR 878.4020 · Occlusive wound dressing.