Home / 510(k) Clearances / K171692

510(k) K171692

Instrument basket, for EndoEYE by Olympus Winter & Ibe GmbH — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2018
Date Received
June 7, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Olympus Winter & Ibe GmbH

  • K252043 — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep p (September 23, 2025)
  • K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessor (August 18, 2023)
  • K221522 — HF-cables (resusable) (January 19, 2023)
  • K223183 — Light-Guide Cables (January 13, 2023)
  • K213207 — Sheath, Stopcock Accessory (December 22, 2021)
  • K203492 — Instrument tray, for semi-rigid ureteroscope (September 15, 2021)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K203682 — Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer an (May 17, 2021)
  • K203277 — Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (April 28, 2021)
  • K200369 — OES Elite Ureteroscopes and Accessories (August 28, 2020)

Other clearances for product code KCT

  • K253791 — PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula Syste (February 26, 2026)
  • K251614 — Stainless Steel Surgical Kits (February 6, 2026)
  • K251756 — Sterilization Trays (November 14, 2025)
  • K243425 — Guided DAS Surgical Kit (July 22, 2025)
  • K251300 — Plastic Surgical Kits (July 22, 2025)
  • K243589 — PAL Sterilization Case (June 20, 2025)
  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K250029 — ONE TRAY® Sealed Sterilization Container System (May 1, 2025)
  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)