Cleared Traditional

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)

K210615 · Thompson Surgical Instruments, Inc. · Neurology

May 2022

Decision

438d

Days

Class 2

Risk

About This 510(k) Submission

K210615 is an FDA 510(k) clearance for the Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM), a Retractor, Self-retaining, For Neurosurgery (Class II — Special Controls, product code GZT), submitted by Thompson Surgical Instruments, Inc. (Traverse, US). The FDA issued a Cleared decision on May 13, 2022, 438 days after receiving the submission on March 1, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4800.

Submission Details

510(k) Number	K210615 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2021
Decision Date	May 13, 2022
Days to Decision	438 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF