# 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

- Pathway: 510(k) (Traditional)
- Applicant: Bolder Surgical, LLC
- Decided: Oct 6, 2020 after 68 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K932293 (1994). 25 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160602: JustRight Surgical Vessel Sealing System, Justright Surgical (2016) Summary page 4.
- K170869: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated, Covidien (2017) Summary page 4.

## Most influential descendants
- K203183: CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) (2021), 2 descendants of its own
- K211579: CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) (2021), 1 descendant of its own
- K253634: CoolSeal Generator® (CSL-200-90) (2026), 0 descendants of its own
- K231012: CoolSeal Trinity (2023), 0 descendants of its own

## Recalls of this device
- Jan 25, 2022 · Class II · Z-0736-2022: A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the

## Indications for use
CoolSeal™ Trinity: 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. 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.. CoolSeal™ Mini: The CoolSeal™ Mini is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediatric populations, wherever vessel ligation is required. The device is contraindicated for use in ENT procedures. CoolSeal™ Generator: 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 with only surgical devices compatible with the CoolSeal™ technology.

Source page: https://510kreport.com/device/K202114
Methodology: https://510kreport.com/methodology