CoolSeal Generator® (CSL-200-90)— 510(k) K253634
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K253634 for CoolSeal Generator® (CSL-200-90), Substantially Equivalent on 2026-06-17. Applicant: Hologic, Inc.. Device class: 2.
Summary
Hologic's CoolSeal Generator (CSL-200-90) is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't describe the generator beyond the model number and the code name.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Hologic filed from Malborough, Massachusetts, as the record spells the town. Review took 210 calendar days (November 19, 2025 to June 17, 2026).
Clearance details
- Applicant
- Hologic, Inc.
- 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
- Traditional
- Location
- Malborough, MA, US
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More clearances from Hologic, Inc.
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.