510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K100992Substantially Equivalent

Neuralmas

Innovative Surgical Solutions, LLC ("Iss"), Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100992 is the FDA 510(k) clearance record for NEURALMAS, a class II device, cleared for Innovative Surgical Solutions, LLC ("Iss") on under FDA product code ETN (Stimulator, Nerve). FDA records list 2 510(k) clearances for Innovative Surgical Solutions, LLC ("Iss"), from to . As of , FDA records show no recalls naming K100992.

Clearance record

Decision date
Received
(168 days to decision)
Product code
ETN Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Innovative Surgical Solutions, LLC ("Iss") 55 Northern Blvd., Great Neck NY
510(k) summary
Summary PDF
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