# K231615: Disposable Endoscopic Bipolar

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Hope Biomedical Science & Technology Co., Ltd.
- Decided: Dec 5, 2023 after 186 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: 4 generations back to K792365 (1979). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172368: Bipolar Micro-Coagulation Forceps, Gunter Bissinger Medizintechnik GmbH (2018) Summary page 6.

## Indications for use
Disposable Endoscopic Bipolar is a sterile, single use electrosurgical instrument intended to conduct electrosurgical current for coagulation of tissue during general surgical procedures.

Source page: https://510kreport.com/device/K231615
Methodology: https://510kreport.com/methodology