510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K882438Substantially Equivalent

Constant Current Peripheral Nerve Stim. #Ns252

Fisher & Paykel Healthcare, Inc., Auckland, New Zealand, NZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882438 is the FDA 510(k) clearance record for CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252, a class II device, cleared for Fisher & Paykel Healthcare, Ltd. on under FDA product code BXN (Stimulator, Nerve, Battery-Powered). FDA records list 86 510(k) clearances for Fisher & Paykel Healthcare, Ltd., from to . As of , FDA records show no recalls naming K882438.

Clearance record

Decision date
Received
(34 days to decision)
Product code
BXN Stimulator, Nerve, Battery-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Fisher & Paykel Healthcare, Ltd. 25 Carbine Rd. Panmure, Auckland, New Zealand, NZ
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