21 CFR Subpart F
Therapeutic Devices
June 25, 2020
§
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
§
876.5030
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
§
876.5365
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
§
876.5970
Hernia support
§
876.5980
Gastrointestinal tube and accessories
§
876.5981
Oral removable palatal space occupying device for weight management and/or weight loss
§
876.5985
Enzyme packed cartridge
§
876.5990
Extracorporeal shock wave lithotripter
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