# K253634: CoolSeal Generator® (CSL-200-90)

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jun 17, 2026 after 210 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K932293 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202114: CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20, Bolder Surgical, LLC (2020) Summary page 5.

## Indications for use
The CoolSeal Generator® is intended to provide Radio Frequency (RF) energy to compatible CoolSeal instruments for vessel sealing applications. The specific application will depend on the compatible surgical device that is connected to the generator. This generator is designed to be used only with surgical devices compatible with the CoolSeal technology.

Source page: https://510kreport.com/device/K253634
Methodology: https://510kreport.com/methodology