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510(k) K912843

FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE by Flexmedics — Product Code HXB

K912843 is an FDA 510(k) premarket notification submitted by Flexmedics for the device "FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE". The FDA issued a decision of Substantially Equivalent on September 24, 1991. The device falls under product code HXB (Probe), a Class I device regulated under 21 CFR 888.4540. Flexmedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1991
Date Received
June 26, 1991
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 Flexmedics

  • K990765 — FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GU (March 15, 1999)
  • K964955 — FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWI (February 14, 1997)
  • K952430 — FINESSE GUIDEWIRE CORONARY (August 18, 1995)
  • K943390 — FLEXFINDER GUIDEWIRE (June 27, 1995)
  • K942074 — FLEXFINDER GUIDEWIRE (June 24, 1994)
  • K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (January 21, 1994)
  • K910674 — FLEXMEDICS MALLEABLE CANNULA (April 12, 1991)
  • K895899 — FLEXMEDICS GUIDEWIRE .012 ONLY (May 23, 1990)
  • K893626 — FLEXMEDICS GUIDEWIRE (September 26, 1989)
  • K885086 — TIN COATED NITI ORTHODONTIC ARCH WIRES (January 10, 1989)

Other clearances for product code HXB

  • K960539 — DIAO HAND SURGERY SET (July 23, 1996)
  • K943472 — COHORT AVB RETRACTOR SYSTEM (October 20, 1994)
  • 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