Home / 510(k) Clearances / K921015

510(k) K921015

SHARPE ENDOSPONGE ASPIIRATOR by Paladin Medical, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1993
Date Received
March 3, 1992
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 Paladin Medical, Inc.

  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K970347 — MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM (August 29, 1997)
  • K971290 — STRATASYS FDM MEDMODELER SYSTEM (June 20, 1997)
  • K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (December 20, 1996)
  • K950054 — ENDO-BEND(TM) SHAVER (June 29, 1995)
  • K935220 — CORE PREVENT MATTRESS MODIFICATION (November 29, 1993)
  • K915743 — SHARPE ENDOTENACULUM (May 20, 1993)
  • K921888 — SHARPE ENDODISSECTOR (October 20, 1992)
  • K915749 — SHARPE ENDOLIGATURE CARRIER (October 20, 1992)
  • K915744 — SHARPE ENDOHEMOSTAT (October 20, 1992)

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)