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510(k) K853601

MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP by Bowen & Company, Inc. — Product Code GAC

K853601 is an FDA 510(k) premarket notification submitted by Bowen & Company, Inc. for the device "MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code GAC (Rasp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Bowen & Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
August 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rasp, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 GAC

  • K884473 — RUBIN BONE PLANER W/REPLACEABLE BLADE (December 9, 1988)

FDA data resources