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510(k) K943472

COHORT AVB RETRACTOR SYSTEM by Cohort Medical Products Group, Inc. — Product Code HXB

K943472 is an FDA 510(k) premarket notification submitted by Cohort Medical Products Group, Inc. for the device "COHORT AVB RETRACTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on October 20, 1994. The device falls under product code HXB (Probe), a Class I device regulated under 21 CFR 888.4540. Cohort Medical Products Group, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1994
Date Received
July 19, 1994
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 Cohort Medical Products Group, Inc.

  • K964975 — COHORT DISCECTOMY SYSTEMS (CDS) (February 24, 1997)
  • K950011 — COHORT(TM) ANTERIOR PLATE SYSTEM (APS) (November 6, 1995)
  • K943804 — BONE SCREW (December 8, 1994)
  • K943474 — CANNULATED BONE SCREW (October 14, 1994)

Other clearances for product code HXB

  • K960539 — DIAO HAND SURGERY SET (July 23, 1996)
  • 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)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • 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