HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI— 510(k) K094009
Substantially EquivalentHalt 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.. Device class: 2.
Clearance details
- Applicant
- Halt Medical, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brentwood, CA, US
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More clearances from Halt Medical, Inc.
view allAdverse 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, through . 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.