# K203640: CoolSeal Reveal

- Pathway: 510(k) (Traditional)
- Applicant: Bolder Surgical, LLC
- Decided: May 6, 2021 after 143 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)
- K173281: LigaSure Exact Dissector, Nano-coated, Covidien (2018) Summary page 4.
- K160602: JustRight Surgical Vessel Sealing System, Justright Surgical (2016) Summary page 4.

## Indications for use
The CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The CoolSeal™ Reveal is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and parotidectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermallysensitive structures such as nerves and parathyroid glands. The CoolSeal™ Reveal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Reveal for these procedures.

Source page: https://510kreport.com/device/K203640
Methodology: https://510kreport.com/methodology