FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.
    - Effective dates of requirement for premarket approval.
    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    - Endoscopic transhepatic venous access needle.
    - Gastroenterology-urology biopsy instrument.
    - Gastroenterology-urology accessories to a biopsy instrument.
    - Ingestible telemetric gastrointestinal capsule imaging system.
    - Colon capsule endoscopy system.
    - Stomach pH electrode.
    - Esophageal tissue characterization system.
    - Endoscope and accessories.
    - Urodynamics measurement system.
    - Gastrointestinal motility monitoring system.
    - Electrogastrography system.
    - Urine flow or volume measuring system.

 - Enuresis alarm.
    - Prostate lesion documentation system.
    - Pressure ulcer management tool.

    - Penile inflatable implant.
    - Penile implant surgical accessories.
    - Penile rigidity implant.
    - Testicular prosthesis.

    - Fiberoptic light ureteral catheter.
    - Colostomy rod.
    - Endoscopic electrosurgical unit and accessories.
    - Endoscopic electrosurgical clip cutting system.
    - High intensity ultrasound system for prostate tissue ablation.
    - Fluid jet system for prostate tissue removal.
    - Gastroenterology-urology evacuator.
    - Hemorrhoidal ligator.
    - Electrohydraulic lithotriptor.
    - Mechanical lithotriptor.
    - Gastroenterology-urology fiberoptic retractor.
    - Ribdam.
    - Interlocking urethral sound.
    - Ureteral stent.
    - Ureteral stent accessories.
    - Water jet renal stone dislodger system.
    - Ureteral stone dislodger.
    - Manual gastroenterology-urology surgical instrument and accessories.
    - Urethrotome.
    - Urological table and accessories.

    - Biliary catheter and accessories.
    - Metallic biliary stent system for benign strictures.
    - Biliary stent, drain, and dilator accessories.
    - Pancreatic drainage stent and delivery system.
    - External penile rigidity devices.
    - Vibrator for climax control of premature ejaculation.
    - Continent ileostomy catheter.
    - Suprapubic urological catheter and accessories.
    - Suprapubic catheter accessories.
    - Urological catheter and accessories.
    - Urethral insert with pump for bladder drainage.
    - Urological clamp.
    - Enema kit.

  - Colonic irrigation system.
    - Urine collector and accessories.
    - Implanted electrical urinary continence device.
    - Implanted mechanical/hydraulic urinary continence device.
    - Implanted mechanical/hydraulic urinary continence device surgical accessories.
    - Nonimplanted, peripheral electrical continence device.
    - Nonimplanted electrical continence device.
    - Transcutaneous electrical continence device.
    - Nonimplanted nerve stimulator for functional abdominal pain relief.
    - Esophageal dilator.
    - Rectal dilator.
    - Ureteral dilator.
    - Urethral dilator.
    - Implantable transprostatic tissue retractor system.
    - Blood access device and accessories.
    - Prostatic artery embolization device.
    - Sorbent regenerated dialysate delivery system for hemodialysis.
    - Peritoneal dialysis system and accessories.
    - Water purification system for hemodialysis.
    - Hemodialysis system and accessories.
    - Hemodialyzer with disposable insert (Kiil type).
    - High permeability hemodialysis system.
    - Sorbent hemoperfusion system.
    - Isolated kidney perfusion and transport system and accessories.
    - Tissue culture media for human ex vivo tissue and cell culture processing applications.
    - Ostomy irrigator.
    - Ostomy pouch and accessories.
    - Protective garment for incontinence.
    - Rectal control system.
    - Peritoneo-venous shunt.
    - Hernia support.
    - Gastrointestinal tube and accessories.
    - Oral removable palatal space occupying device for weight management and/or weight loss.
    - Ingested, transient, space occupying device for weight management and/or weight loss.
    - Enzyme packed cartridge.
    - Extracorporeal shock wave lithotripter.

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

Extracted from US.FDA