510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K885120Substantially Equivalent

Esi Model Ms-103

Electrical Systems Div., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885120 is the FDA 510(k) clearance record for ESI MODEL MS-103, a class II device, cleared for Electrical Systems Div. on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list one 510(k) clearance for Electrical Systems Div. As of , FDA records show no recalls naming K885120.

Clearance record

Decision date
Received
(403 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
Device class
Class II
Review panel
Neurology
Applicant
Electrical Systems Div. 8918 Tesoro Dr., San Antonio TX
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