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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 876 - Gastroenterology-Urology 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 - xxx |
| § 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 - xxx |
| § 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. |
| § 876.4330 - Endoscopic pancreatic debridement device. |
| § 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 - xxx |
| § 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 - xxx |
| § 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 - xxx |
| § 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 - xxx |
| § 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. |
| § 876.5861 - Pediatric continuous renal replacement therapy system. |
| § 876.5862 - Hemodialyzer with expanded solute removal profile. |
| § 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. |