510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K162048Substantially Equivalent

EZstim*III Peripheral Nerve Stimulator/Nerve Locator

Halyard Health - Irvine, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162048 is the FDA 510(k) clearance record for EZstim*III Peripheral Nerve Stimulator/Nerve Locator, a class II device, cleared for Halyard Health - Irvine on under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric). FDA records list one 510(k) clearance for Halyard Health - Irvine. As of , FDA records show no recalls naming K162048.

Clearance record

Decision date
Received
(133 days to decision)
Product code
KOI Stimulator, Nerve, Peripheral, Electric
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Halyard Health - Irvine 43 Discovery, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KOI

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