Bowen Suture Passer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K863146 ↗

FDA Product Code

HXI

Device Class

Class I

Regulation

21 CFR Part 888.4540

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Bowen Cannula

  Class I

  FDA 510(k) K863150 Active Cleared 5 Sep 1986

• Bowen Knot Passer

  Class I

  FDA 510(k) K863148 Active Cleared 5 Sep 1986

• Sternal Power Awl

  Class I

  FDA 510(k) K873766 Active Cleared 14 Nov 1988

• Morgan Arthroscopic Menesus & Synovial Rasp

  Class I

  FDA 510(k) K853601 Active Cleared 16 Sep 1985

• Disposable 45 Degree Shaver

  Class II

  FDA 510(k) K896538 Active Cleared 6 Dec 1989

• Bowen Reuseable/Disposable Electrode

  Class II

  FDA 510(k) K871325 Active Cleared 8 Jun 1987

See all devices from Bowen & Company, Inc. →