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510(k) K214041

Aesculap AICON Container by Aesculap, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2022
Date Received
December 23, 2021
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 Aesculap, Inc.

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  • K223596 — SQ.line KERRISON (June 29, 2023)
  • K211572 — Aesculap Slim Clip Applier (December 13, 2021)
  • K203739 — ELAN 4 Electro Motor System (August 24, 2021)
  • K202391 — DIR 800 (January 21, 2021)
  • K203461 — Aesculap Caiman 12 Seal and Cut Technology System (December 18, 2020)
  • K202938 — Aesculap Caiman 5 Seal and Cut Technology System (October 30, 2020)
  • K202124 — Aesculap PAS-Port Proximal Anastomosis System (September 2, 2020)
  • K200950 — Ventricular Catheter (May 8, 2020)

Other clearances for product code KCT

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  • 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)