510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K060097Substantially Equivalent

Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00

KLS-Martin L.P., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060097 is the FDA 510(k) clearance record for GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00, a class II device, cleared for KLS-Martin L.P. on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list 78 510(k) clearances for KLS-Martin L.P., from to . As of , FDA records show no recalls naming K060097.

Clearance record

Decision date
Received
(45 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
Device class
Class II
Review panel
Neurology
Applicant
KLS-Martin L.P. 11239 St. Johns Industrial, Jacksonville FL
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 November 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260