NEURALMAS— 510(k) K100992

Substantially Equivalent

Innovative Surgical Solutions, LLC ("Iss")

FDA 510(k) clearance K100992 for NEURALMAS, Substantially Equivalent on 2010-09-24. Applicant: Innovative Surgical Solutions, LLC ("Iss").

Clearance details

Applicant: Innovative Surgical Solutions, LLC ("Iss")
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2010-04-09
Decision date: 2010-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.