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510(k) K921006

LAPAROSCOPIC RETRACTOR SYSTEM by Laparomed Corp. — Product Code GCS

K921006 is an FDA 510(k) premarket notification submitted by Laparomed Corp. for the device "LAPAROSCOPIC RETRACTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on July 28, 1992. The device falls under product code GCS (Endoscope, Battery-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500. Laparomed Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1992
Date Received
March 3, 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 Laparomed Corp.

  • K934527 — FASCIA STITCHER (February 25, 1994)
  • K930569 — LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM (April 20, 1993)
  • K921921 — CATHETER CHOLANGIOGRAPHY (August 17, 1992)
  • K921053 — LAPAROMED LIGATING LOOP (August 6, 1992)
  • K914066 — ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS (November 7, 1991)
  • K910074 — LAPAROMED HOOK/SPATULA DEVICE (July 2, 1991)
  • K910218 — LAPAROMED CHOLANGIOGRAM VACUUM DEVICE (April 8, 1991)
  • K910219 — LAPAROMED CHOLANGIOGRAM DEVICE (April 8, 1991)
  • K905722 — SUTURE APPLIER DEVICE (March 14, 1991)

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)
  • 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)

FDA data resources