Cleared Traditional

K920979 - CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)
(FDA 510(k) Clearance)

K920979 · Codman & Shurtleff, Inc. · Gastroenterology & Urology device

Mar 1993

Decision

386d

Days

Class 2

Risk

K920979 is an FDA 510(k) clearance for the CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340). This device is classified as a Endoscope, Flexible (Class II - Special Controls, product code GCQ).

Submitted by Codman & Shurtleff, Inc. (Attleboro, US). The FDA issued a Cleared decision on March 23, 1993, 386 days after receiving the submission on March 2, 1992.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K920979 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 1992
Decision Date	March 23, 1993
Days to Decision	386 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF