Home / 510(k) Clearances / K950457

510(k) K950457

CANNUAL AND TROCAR, SUPERPUBIC by Core Dynamics, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1995
Date Received
February 3, 1995
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 Core Dynamics, Inc.

  • K992250 — CORE AUDIBLE TROCAR II (September 24, 1999)
  • K992190 — CORE POUCH (September 1, 1999)
  • K955490 — LAPAROSCOPIC KNITTER (January 22, 1996)
  • K953903 — LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM (October 20, 1995)
  • K953409 — LAPAROSCOPIC TROCAR (October 16, 1995)
  • K943172 — CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR (July 28, 1994)
  • K935826 — LAPAROSCOPIC/SUCTION/IRRIGATION PROBE (May 18, 1994)
  • K932118 — ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET (March 17, 1994)
  • K932021 — ENTREE CANNULA FASCIA ANCHORS (January 11, 1994)
  • K932020 — ENTREE BLUNT TIP TROCAR AND ADAPTER (January 11, 1994)

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)