510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854568Substantially Equivalent

V. Mueller Pneumo-Intestinal 15 Vascular & 30 Stap

American V. Mueller, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854568 is the FDA 510(k) clearance record for V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP, a class I device, cleared for American V. Mueller on under FDA product code GEF (Applier, Staple, Surgical,). FDA records list 31 510(k) clearances for American V. Mueller, from to . As of , FDA records show no recalls naming K854568.

Clearance record

Decision date
Received
(18 days to decision)
Product code
GEF Applier, Staple, Surgical,
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
American V. Mueller 6600 W. Touhy, Chicago IL
Third party review
No

Clearances, product code GEF

Trailing 12 months

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

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