Home / 510(k) Clearances / K914923

510(k) K914923

UNISURGE DISPOSABLE TROCAR by Unisurge, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1992
Date Received
November 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Unisurge, Inc.

  • K943502 — UNIGRIP (October 7, 1994)
  • K933720 — INSTRUMENT ACTUATING DEVICE (IAD) (November 12, 1993)
  • K930605 — APPLIER, SURGICAL, CLIP (October 8, 1993)
  • K930617 — OBGRIP AND UNITIPS(TM) (August 11, 1993)
  • K925882 — UNITIPS SURGICAL INSTRUMENTS (August 10, 1993)
  • K932604 — UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC (August 10, 1993)
  • K925917 — UNICHANNEL(TM SURGICAL GRASPER (August 10, 1993)
  • K930809 — UNITIPS (August 10, 1993)
  • K926341 — UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT (May 17, 1993)
  • K926199 — UNICLIP SURGICAL CLIP APPLIER (April 20, 1993)

Other clearances for product code HET

  • K250939 — SIRIUS Endoscope System (PR-SI-1230) (August 29, 2025)
  • K243821 — i-Cut (April 25, 2025)
  • K221642 — SIRIUS Endoscope System (December 12, 2022)
  • K210116 — Video Endoscopy System, 3D Video Endoscopy System (October 13, 2021)
  • K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (September 17, 2021)
  • K210104 — SurroundScope System (July 8, 2021)
  • K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera (March 12, 2021)
  • K200216 — 4K UHD Camera System (August 21, 2020)
  • K200638 — LAP-iX Suction Irrigation (April 3, 2020)
  • K190190 — WV1 Endoscope (November 1, 2019)