510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853601Substantially Equivalent

Morgan Arthroscopic Menesus & Synovial Rasp

Bowen & Company, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853601 is the FDA 510(k) clearance record for MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP, a class I device, cleared for Bowen & Company, Inc. on under FDA product code GAC (Rasp, Surgical, General & Plastic Surgery). FDA records list 14 510(k) clearances for Bowen & Company, Inc., from to . As of , FDA records show no recalls naming K853601.

Clearance record

Decision date
Received
(20 days to decision)
Product code
GAC Rasp, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Bowen & Company, Inc. 1800 Chapman Ave., Rockville MD
Third party review
No

Clearances, product code GAC

Trailing 12 months

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

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