# K203183: CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)

- Pathway: 510(k) (Traditional)
- Applicant: Bolder Surgical, LLC
- Decided: May 6, 2021 after 191 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.
2 later devices descend from it; 1 cites it directly.
0 of 29 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 4.
- K160602: JustRight Surgical Vessel Sealing System, Justright Surgical (2016) Summary page 4.

## Most influential descendants
- K211579: CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) (2021), 1 descendant of its own
- K231012: CoolSeal Trinity (2023), 0 descendants of its own

## Indications for use
The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on arteries up to and including 6 mm, veins, and vascular bundles up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

Source page: https://510kreport.com/device/K203183
Methodology: https://510kreport.com/methodology