# K250674: Vessel Sealer Curved (480522)

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jun 13, 2025 after 99 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K930667 (1994). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183107: Intuitive Surgical Vessel Sealer Extend, Intuitive Surgical, Inc. (2018) Summary page 5.

## Indications for use
The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Source page: https://510kreport.com/device/K250674
Methodology: https://510kreport.com/methodology