510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883807Substantially Equivalent

Axostim

Singer Medical Products, Inc., Bensenville IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883807 is the FDA 510(k) clearance record for AXOSTIM, a class II device, cleared for Singer Medical Products, Inc. on under FDA product code BXN (Stimulator, Nerve, Battery-Powered). FDA records list 8 510(k) clearances for Singer Medical Products, Inc., from to . As of , FDA records show no recalls naming K883807.

Clearance record

Decision date
Received
(154 days to decision)
Product code
BXN Stimulator, Nerve, Battery-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Singer Medical Products, Inc. 790 Maple Ln., Bensenville IL
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