510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871978Substantially Equivalent

Codman Flexible Endoscope

Cerenovus, Inc., Randolph MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871978 is the FDA 510(k) clearance record for CODMAN FLEXIBLE ENDOSCOPE, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code GCQ (Endoscope, Flexible). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K871978.

Clearance record

Decision date
Received
(95 days to decision)
Product code
GCQ Endoscope, Flexible
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Codman & Shurtleff, Inc. 41 Pacella Park Dr., Randolph MA
Third party review
No

Clearances, product code GCQ

Trailing 12 months

FDA records hold no clearances under product code GCQ in the trailing twelve months.

FDA records show no clearances under product code GCQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260