Cleared Special

TCAT TKA Instrument Tray Set

K200632 · THINK Surgical, Inc. · General Hospital

Apr 2020

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K200632 is an FDA 510(k) clearance for the TCAT TKA Instrument Tray Set, 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 April 8, 2020, 29 days after receiving the submission on March 10, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K200632 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2020
Decision Date	April 08, 2020
Days to Decision	29 days
Submission Type	Special
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