510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895395Substantially Equivalent

V. Mueller Rhoton Self-Retaining Brain Retractor

Baxter Healthcare Corporation, Niles IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895395 is the FDA 510(k) clearance record for V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR, a class II device, cleared for Baxter Healthcare Corp on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K895395.

Clearance record

Decision date
Received
(48 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
Device class
Class II
Review panel
Neurology
Applicant
Baxter Healthcare Corp 7280 N. Caldwell, Niles IL
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