510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142432Substantially Equivalent

StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit

Bioness, Inc., Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K142432 is the FDA 510(k) clearance record for StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit, a class II device, cleared for Bioness, Inc. on under FDA product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)). FDA records list 13 510(k) clearances for Bioness, Inc., from to . As of , FDA records show no recalls naming K142432.

Clearance record

Decision date
Received
(175 days to decision)
Product code
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation
21 CFR 882.5870
Device class
Class II
Review panel
Neurology
Applicant
Bioness, Inc. 25103 Rye Canyon Loop, Valencia CA
510(k) summary
Statement
Third party review
No

Clearances, product code GZF

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