Cleared Traditional

MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE

K812965 · American Optical Corp. · Gastroenterology & Urology

Nov 1981

Decision

11d

Days

Class 2

Risk

About This 510(k) Submission

K812965 is an FDA 510(k) clearance for the MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE, 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 November 2, 1981, 11 days after receiving the submission on October 22, 1981. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K812965 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 22, 1981
Decision Date	November 02, 1981
Days to Decision	11 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