Home / 510(k) Clearances / K944062

510(k) K944062

LAPRASCOPIC GRASPER by Instrument Makar, Inc. — Product Code GCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1995
Date Received
August 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Battery-Powered And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Instrument Makar, Inc.

  • K002600 — LITWIN CRUICATE ANCHOR (November 15, 2000)
  • K980999 — ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT (November 6, 1998)
  • K963396 — BIOSPHERE SUTURE ANCHOR (May 6, 1997)
  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH (November 19, 1996)
  • K960555 — BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR (July 9, 1996)
  • K943249 — BIOABSORBABLE INTERFERENCE SCREW (July 31, 1995)
  • K942828 — MAKAR FULL AND HALF FACE SHIELD (February 23, 1995)
  • K930980 — INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW (February 10, 1994)
  • K923841 — BONE SCREWS (October 27, 1993)

Other clearances for product code GCS

  • K944067 — PEANUT WAND, MODIFICATION (December 8, 1994)
  • K933201 — AESCULAP TROCAR INSTRUMENT SET (September 13, 1993)
  • K932762 — 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (August 31, 1993)
  • K933371 — IMC ENDOSCOPIC INSTRUMENT HOLDER (August 6, 1993)
  • K924134 — LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS (July 2, 1993)
  • K931340 — GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR (July 1, 1993)
  • K925276 — M.I.S. TROCAR-CANNULA (May 24, 1993)
  • K921006 — LAPAROSCOPIC RETRACTOR SYSTEM (July 28, 1992)