510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921120Substantially Equivalent

Flexible Cystoscopy Introducing Catheter

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921120 is the FDA 510(k) clearance record for FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER, a class II device, cleared for Cook Urological, Inc. on under FDA product code FED (Endoscopic Access Overtube, Gastroenterology-Urology). FDA's definition for product code FED reads: "To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation". FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K921120.

Clearance record

Decision date
Received
(148 days to decision)
Product code
FED Endoscopic Access Overtube, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Statement
Third party review
No

Clearances, product code FED

Trailing 12 months
5 clearances under product code FED in the twelve months to November 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FED, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20263
October 20260
November 20260