510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905035Substantially Equivalent

Axostim Nerve Stimulator, Modification

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

K905035 is the FDA 510(k) clearance record for AXOSTIM NERVE STIMULATOR, MODIFICATION, a class II device, cleared for Singer Medical Products, Inc. on under FDA product code ETN (Stimulator, Nerve). FDA records list 8 510(k) clearances for Singer Medical Products, Inc., from to . As of , FDA records show no recalls naming K905035.

Clearance record

Decision date
Received
(176 days to decision)
Product code
ETN Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Singer Medical Products, Inc. 790 Maple Ln., Bensenville IL
Third party review
No

Clearances, product code ETN

Trailing 12 months
2 clearances under product code ETN in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260