HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI— 510(k) K094009

Substantially Equivalent

Halt Medical, Inc.

FDA 510(k) clearance K094009 for HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI, Substantially Equivalent on 2010-06-14. Applicant: Halt Medical, Inc..

Clearance details

Applicant: Halt Medical, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2009-12-28
Decision date: 2010-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brentwood, CA, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.