Home / 510(k) Clearances / K924134

510(k) K924134

LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS by Leisegang Medical, Inc. — Product Code GCS

K924134 is an FDA 510(k) premarket notification submitted by Leisegang Medical, Inc. for the device "LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS". The FDA issued a decision of Substantially Equivalent on July 2, 1993. The device falls under product code GCS (Endoscope, Battery-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500. Leisegang Medical, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1993
Date Received
August 18, 1992
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 Leisegang Medical, Inc.

  • K990043 — SMOOTHLASE ALEXANDRITE LASER SYSTEM (February 11, 1999)
  • K940094 — COLPOSCOPES AND ACCESSORIES (April 25, 1995)
  • K920217 — MAX-E-VAC (July 23, 1992)
  • K914201 — LM- LAP 10 HIGH FLOW INSUFFLATOR (January 9, 1992)
  • K912789 — LM-100/200LOW FLOW INSUFFLATOR (September 20, 1991)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K911212 — LM-150HT LIGHT SOURCE (May 23, 1991)
  • K902313 — LM-1Z ZOOM SCOPE (September 4, 1990)
  • K854767 — LM 1000 (January 24, 1986)

Other clearances for product code GCS

  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • 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)
  • 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)

FDA data resources