Home / 510(k) Clearances / K180127

510(k) K180127

TCAT (R) THA Instrument Tray Set by THINK Surgical, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2019
Date Received
January 17, 2018
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 THINK Surgical, Inc.

  • K260010 — TMINI® Miniature Robotic System (March 3, 2026)
  • K253661 — TMINI Miniature Robotic System (December 22, 2025)
  • K252544 — TMINI Miniature Robotic System (October 10, 2025)
  • K250877 — TMINI Miniature Robotic System (June 20, 2025)
  • K243481 — TMINI Miniature Robotic System (January 6, 2025)
  • K243285 — TMINI Miniature Robotic System (November 15, 2024)
  • K242264 — TMINI Miniature Robotic System (August 23, 2024)
  • K241031 — TMINI Miniature Robotic System (TMINI 1.1) (July 12, 2024)
  • K232802 — TMINI™ Miniature Robotic System (October 12, 2023)
  • K230202 — TMINI™ Miniature Robotic System (April 25, 2023)

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)