Cleared Traditional

TCAT (R) THA Instrument Tray Set

K180127 · THINK Surgical, Inc. · General Hospital

Mar 2019

Decision

422d

Days

Class 2

Risk

About This 510(k) Submission

K180127 is an FDA 510(k) clearance for the TCAT (R) THA 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 March 15, 2019, 422 days after receiving the submission on January 17, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K180127 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2018
Decision Date	March 15, 2019
Days to Decision	422 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