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510(k) K863146

BOWEN SUTURE PASSER by Bowen & Company, Inc. — Product Code HXI

K863146 is an FDA 510(k) premarket notification submitted by Bowen & Company, Inc. for the device "BOWEN SUTURE PASSER". The FDA issued a decision of Substantially Equivalent on September 5, 1986. The device falls under product code HXI (Passer, Wire, Orthopedic), a Class I device regulated under 21 CFR 888.4540. Bowen & Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1986
Date Received
August 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Passer, Wire, Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Bowen & Company, Inc.

  • K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER (April 4, 1990)
  • K896538 — DISPOSABLE 45 DEGREE SHAVER (December 6, 1989)
  • K873766 — STERNAL POWER AWL (November 14, 1988)
  • K872098 — CREMEEN ALVEOLAR BONE CALIPER (July 31, 1987)
  • K871325 — BOWEN REUSEABLE/DISPOSABLE ELECTRODE (June 8, 1987)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K870881 — LOOSE BODY GRASPERS (March 23, 1987)
  • K863148 — BOWEN KNOT PASSER (September 5, 1986)
  • K863150 — BOWEN CANNULA (September 5, 1986)
  • K863149 — BOWEN PROBE (September 5, 1986)

Other clearances for product code HXI

  • K140576 — Y WIRE 2 (May 20, 2014)
  • K863148 — BOWEN KNOT PASSER (September 5, 1986)

FDA data resources