Home / 510(k) Clearances / K964450

510(k) K964450

SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT by Pilling Weck Group — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
November 6, 1996
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 Pilling Weck Group

  • K971334 — PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR (June 11, 1997)
  • K965176 — PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS (March 4, 1997)
  • K964123 — REUSABLE TROCAR WITH SLEEVE (COMMON) (December 12, 1996)
  • K963815 — REUSABLE TROCAR WITH SLEEVE (COMMON) (November 5, 1996)

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)