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510(k) K863149

BOWEN PROBE by Bowen & Company, Inc. — Product Code HXB

K863149 is an FDA 510(k) premarket notification submitted by Bowen & Company, Inc. for the device "BOWEN PROBE". The FDA issued a decision of Substantially Equivalent on September 5, 1986. The device falls under product code HXB (Probe), 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
Probe
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)
  • K863146 — BOWEN SUTURE PASSER (September 5, 1986)

Other clearances for product code HXB

  • K960539 — DIAO HAND SURGERY SET (July 23, 1996)
  • K943472 — COHORT AVB RETRACTOR SYSTEM (October 20, 1994)
  • K912843 — FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (September 24, 1991)
  • K890227 — SURGICAL PROBE (January 27, 1989)
  • K873652 — HOOK PROBE #TM-1376 (November 2, 1987)
  • K873651 — BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 (November 2, 1987)
  • K841971 — 2.5MM & 4MM PROBE K841969-LABELING (June 19, 1984)
  • K840558 — SHUTT PRECISION PROBES (April 25, 1984)
  • K810294 — LINE CADDY (February 26, 1981)
  • K802951 — I.M PROBES (December 17, 1980)

FDA data resources