FDA 21 CFR Part 876 Gastroenterology and Urology Devices

FDA 21 CFR Part 876 Gastroenterology and Urology Devices

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Table of contents

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

876.1075 Gastroenterology-urology biopsy instrument.

876.1080 Gastroenterology-urology accessories to a biopsy instrument.

876.1300 Ingestible telemetric gastrointestinal capsule imaging system.

876.1330 Colon capsule endoscopy system.

876.1400 Stomach pH electrode.

876.1500 Endoscope and accessories.

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.

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, (and)

Subpart F - Therapeutic Devices

FDA 21 CFR Part 876 Gastroenterology and Urology Devices:

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