K242541
- 510(k) number
- K242541
- Device name
- GEM ZIPCLIP
- Applicant
- Synovis Micro Companies Alliance A Subsidiary of Baxter Int AL · US
- Product code
- FZP — Clip, Implantable
- Decision date
- 2025-01-15
- Date received
- 2024-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242541.pdf
Official FDA record: K242541
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.