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
K863146Substantially Equivalent

Bowen Suture Passer

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

K863146 is the FDA 510(k) clearance record for BOWEN SUTURE PASSER, a class I device, cleared for Bowen & Company, Inc. on under FDA product code HXI (Passer, Wire, Orthopedic). FDA records list 14 510(k) clearances for Bowen & Company, Inc., from to . As of , FDA records show no recalls naming K863146.

Clearance record

Decision date
Received
(21 days to decision)
Product code
HXI Passer, Wire, Orthopedic
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Bowen & Company, Inc. 1800 Chapman Ave., Rockville MD
Third party review
No

Clearances, product code HXI

Trailing 12 months

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

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