Cleared Traditional

FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3

K820790 · American Optical Corp. · Gastroenterology & Urology

Apr 1982

Decision

Days

Class 2

Risk

About This 510(k) Submission

K820790 is an FDA 510(k) clearance for the FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3, a Sigmoidoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FAM), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982, 9 days after receiving the submission on March 23, 1982. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K820790 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 1982
Decision Date	April 01, 1982
Days to Decision	9 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—

Device Classification

Product Code	FAM — Sigmoidoscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Examine And Perform Procedures Within The Sigmoid (descending) Colon