# K231732: CleanSeal Advanced Bipolar Vessel Sealer Maryland

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Oct 23, 2023 after 132 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170869: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated, Covidien (2017) Summary page 5.
- K181085: LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated, Covidien (2018) Summary page 5.

## Indications for use
CONMED CleanSeal Vessel Sealers are intended to be used in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm vessels (arteries, veins, pulmonary arteries, pulmonary veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, thoracic, and vascular. These procedures include, but are not limited to, hysterectomies, oophorectomies, colectomies, Nissen fundoplication, and adhesiolysis. CleanSeal vessel sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use CleanSeal vessel sealer for these procedures.

Source page: https://510kreport.com/device/K231732
Methodology: https://510kreport.com/methodology