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510(k) K933772

PUNCH SURGICAL by Mahe-Medizintechnik — Product Code LXH

K933772 is an FDA 510(k) premarket notification submitted by Mahe-Medizintechnik for the device "PUNCH SURGICAL". The FDA issued a decision of Substantially Equivalent on February 1, 1994. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Mahe-Medizintechnik has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1994
Date Received
July 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Mahe-Medizintechnik

  • K942821 — MAHE INSTRUMENTS (November 2, 1994)
  • K942819 — TROCAR WITH SHIELD (August 23, 1994)
  • K933768 — COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES (June 27, 1994)
  • K933767 — FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY (May 26, 1994)
  • K933770 — FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE (March 23, 1994)
  • K935442 — MAHE INSTRUMENTS (March 14, 1994)
  • K925624 — MICROSURGICAL INSTRUMENTS (July 22, 1993)

Other clearances for product code LXH

  • K192873 — SX-One MicroKnife (December 20, 2019)
  • K140414 — IMBIBE NEEDLE (April 1, 2014)
  • K101609 — SELF RETAINING SOFT TISSUE RETRACTOR (December 9, 2010)
  • K001507 — MICROPERFORATION INSTRUMENT (June 14, 2000)
  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944188 — SPINAL MARKER (April 13, 1995)
  • K941896 — STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (November 7, 1994)
  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)

FDA data resources