510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182832Unknown

Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set

Cook Incorporated, Bloomington IN / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182832 is the FDA 510(k) clearance record for Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set, a class II device, cleared for Cook Incorporated on under FDA product code KGC (Tube, Gastro-Enterostomy). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K182832.

Clearance record

Decision date
Received
(260 days to decision)
Product code
KGC Tube, Gastro-Enterostomy
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Incorporated 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGC

Trailing 12 months

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

FDA records show no clearances under product code KGC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGC, 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