GEM ZIPCLIP— 510(k) K242541
Substantially EquivalentSynovis Micro Companies Alliance A Subsidiary of Baxter Int
FDA 510(k) clearance K242541 for GEM ZIPCLIP, Substantially Equivalent on 2025-01-15. Applicant: Synovis Micro Companies Alliance A Subsidiary of Baxter Int.
Clearance details
- Applicant
- Synovis Micro Companies Alliance A Subsidiary of Baxter Int
- Product code
- Code FZP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Adverse events under product code FZP
product code FZP- Death
- 11
- Injury
- 726
- Malfunction
- 10,830
- Other
- 1
- Total
- 11,568
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.