Cleared Traditional

AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE

K792179 · American Optical Corp. · Gastroenterology & Urology

Dec 1979

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K792179 is an FDA 510(k) clearance for the AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE, a Colonoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDF), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979, 38 days after receiving the submission on October 29, 1979. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K792179 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 1979
Decision Date	December 06, 1979
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—

Device Classification

Product Code	FDF — Colonoscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).