Cleared Traditional

K871978 - CODMAN FLEXIBLE ENDOSCOPE

K871978 is an FDA 510(k) clearance for CODMAN FLEXIBLE ENDOSCOPE, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCQ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K871978 · Codman & Shurtleff, Inc. · Gastroenterology & Urology device
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Aug 1987
Decision
95d
Days
Class 2
Risk

K871978 is an FDA 510(k) clearance for the CODMAN FLEXIBLE ENDOSCOPE. Classified as Endoscope, Flexible (product code GCQ), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on August 25, 1987 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K871978

510(k) Number K871978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1987
Decision Date August 25, 1987
Days to Decision 95 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 131d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCQ Device Classification - Class 2, Special Controls

Product Code GCQ Endoscope, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCQ Endoscope, Flexible

Devices cleared under the same product code (GCQ) and FDA review panel - the closest regulatory comparables to K871978.
CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)
K920979 · Codman & Shurtleff, Inc. · Mar 1993
MEDILASE SERIES 2100 ENDOSCOPE
K900894 · Medical Laser, Inc. · Jun 1990
TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.
K864960 · Cooper Lasersonics, Inc. · Feb 1987
VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE
K860771 · Van-Tec, Inc. · Apr 1986
K871978 · CODMAN FLEXIBLE ENDOSCOPE
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