K253634
- 510(k) number
- K253634
- Device name
- CoolSeal Generator® (CSL-200-90)
- Applicant
- Hologic, Inc. MA · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-06-17
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K253634.pdf
Official FDA record: K253634
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.