Home / 510(k) Clearances / K925276

510(k) K925276

M.I.S. TROCAR-CANNULA by M.I.S. Technology, Inc. — Product Code GCS

K925276 is an FDA 510(k) premarket notification submitted by M.I.S. Technology, Inc. for the device "M.I.S. TROCAR-CANNULA". The FDA issued a decision of Substantially Equivalent on May 24, 1993. The device falls under product code GCS (Endoscope, Battery-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1993
Date Received
October 20, 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 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)
  • K921006 — LAPAROSCOPIC RETRACTOR SYSTEM (July 28, 1992)

FDA data resources