HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES— 510(k) K183009
Substantially EquivalentHemostatix Medical Technologies, LLC
FDA 510(k) clearance K183009 for HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES, Substantially Equivalent on 2018-11-26. Applicant: Hemostatix Medical Technologies, LLC. Device class: 2.
Clearance details
- Applicant
- Hemostatix Medical Technologies, LLC
- 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
- Special
- Location
- Bartlett, TN, US
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More clearances from Hemostatix Medical Technologies, LLC
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.