INVISIPORT— 510(k) K141146

Substantially Equivalent

Stealth Therapeutics, Incorporated

FDA 510(k) clearance K141146 for INVISIPORT, Substantially Equivalent on 2015-05-01. Applicant: Stealth Therapeutics, Incorporated.

Clearance details

Applicant: Stealth Therapeutics, Incorporated
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2014-05-05
Decision date: 2015-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Stoughton, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJT

product code LJT

Death: 234
Injury: 6,468
Malfunction: 5,326
Other: 2
Total: 12,030

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.