WOUND-EVAC— 510(k) K813341
Substantially EquivalentHeritage Medical Products
FDA 510(k) clearance K813341 for WOUND-EVAC, Substantially Equivalent on 1981-12-18. Applicant: Heritage Medical Products.
Clearance details
- Applicant
- Heritage Medical Products
- Product code
- Code GCY
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Adverse events under product code GCY
product code GCY- Malfunction
- 786
- Other
- 1
- Total
- 787
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.