510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210615Substantially Equivalent

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

Thompson Surgical Instruments, Inc., Traverse MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210615 is the FDA 510(k) clearance record for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM), a class II device, cleared for Thompson Surgical Instruments, Inc. on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list 3 510(k) clearances for Thompson Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K210615.

Clearance record

Decision date
Received
(438 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
Device class
Class II
Review panel
Neurology
Applicant
Thompson Surgical Instruments, Inc. 10341 E Cherry Bend Rd., Traverse MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZT

Trailing 12 months
1 clearance under product code GZT in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260