Cleared Traditional

TCAT TKA Instrument Tray

K203468 · THINK Surgical, Inc. · General Hospital

Dec 2021

Decision

390d

Days

Class 2

Risk

About This 510(k) Submission

K203468 is an FDA 510(k) clearance for the TCAT TKA Instrument Tray, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by THINK Surgical, Inc. (Fremont, US). The FDA issued a Cleared decision on December 20, 2021, 390 days after receiving the submission on November 25, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K203468 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2020
Decision Date	December 20, 2021
Days to Decision	390 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850