TWINTRODE ELC 134 ELECTRODE— 510(k) K012785

Name: FDA 510(k) clearance K012785
Creator: U.S. Food and Drug Administration
Published: 2001-11-16

Substantially Equivalent

Healthtronics Surgical Services, Inc.

FDA 510(k) clearance K012785 for TWINTRODE ELC 134 ELECTRODE, Substantially Equivalent on 2001-11-16. Applicant: Healthtronics Surgical Services, Inc.. Device class: 2.

Clearance details

Applicant: Healthtronics Surgical Services, Inc.
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2001-08-20
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

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.