510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143095Substantially Equivalent

MiniStim MS-IVB Peripheral Nerve Stimulator

Halyard Health, Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143095 is the FDA 510(k) clearance record for MiniStim MS-IVB Peripheral Nerve Stimulator, a class II device, cleared for Halyard Health, Inc. on under FDA product code BXN (Stimulator, Nerve, Battery-Powered). FDA records list 96 510(k) clearances for Halyard Health, Inc., from to . As of , FDA records show no recalls naming K143095.

Clearance record

Decision date
Received
(147 days to decision)
Product code
BXN Stimulator, Nerve, Battery-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Halyard Health, Inc. 1400 Holcomb Bridge Rd., Roswell GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BXN

Trailing 12 months

FDA records hold no clearances under product code BXN in the trailing twelve months.

FDA records show no clearances under product code BXN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BXN, 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 20260
October 20260