510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K182542Substantially Equivalent

The EPAD 2 System

Safeop Surgical, Inc., Hunt Valley MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182542 is the FDA 510(k) clearance record for The EPAD 2 System, a class II device, cleared for Safeop Surgical, Inc. on under FDA product code GWF (Stimulator, Electrical, Evoked Response). FDA records list 2 510(k) clearances for Safeop Surgical, Inc., from to . As of , FDA records show no recalls naming K182542.

Clearance record

Decision date
Received
(158 days to decision)
Product code
GWF Stimulator, Electrical, Evoked Response
Regulation
21 CFR 882.1870
Device class
Class II
Review panel
Neurology
Applicant
Safeop Surgical, Inc. 11350 Mccormick Rd., Suite 1003, Hunt Valley MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWF

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