TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE— 510(k) K092366

Name: FDA 510(k) clearance K092366
Creator: U.S. Food and Drug Administration
Published: 2010-03-04

Substantially Equivalent

Thermal Therapeutic Systems, Inc.

FDA 510(k) clearance K092366 for TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE, Substantially Equivalent on 2010-03-04. Applicant: Thermal Therapeutic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Thermal Therapeutic Systems, Inc.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2009-08-05
Decision date: 2010-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moon Township, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.