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510(k) K203198

KARL STORZ Metal Sterilization Trays by Karl Storz Endoscopy America, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2021
Date Received
October 29, 2020
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 Karl Storz Endoscopy America, Inc.

  • K240506 — KARL STORZ Holders (October 22, 2024)
  • K223885 — HOPKINS Telescopes (September 14, 2023)
  • K230359 — KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (3 (June 23, 2023)
  • K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable (March 17, 2023)
  • K221004 — HOPKINS Telescopes (December 20, 2022)
  • K222504 — H1 (November 10, 2022)
  • K213194 — HD Mediastinoscope (June 23, 2022)
  • K221174 — Telepack + (May 13, 2022)
  • K212458 — Flexible Video-Uretero-Renoscope SSU System (January 20, 2022)
  • K212656 — Flexible Intubation Video Endoscope – Sterile (FIVE-S) (December 29, 2021)

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)