510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223916Substantially Equivalent

PUMA-G System

CoapTech, Inc., Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223916 is the FDA 510(k) clearance record for PUMA-G System, a class II device, cleared for Coaptech, Inc. on under FDA product code KGC (Tube, Gastro-Enterostomy). FDA records list 3 510(k) clearances for Coaptech, Inc., from to . As of , FDA records show no recalls naming K223916.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KGC Tube, Gastro-Enterostomy
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Coaptech, Inc. 101 W. Dickman St., Baltimore MD
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