# K130305: Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size

- Pathway: 510(k) (Traditional)
- Applicant: Lina Medical Aps
- Decided: Jul 24, 2013 after 169 days
- Product code: HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K936109 (1994). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070315: Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8, Lina Medical Aps (2007) Summary page 2.
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill), Gyrus Acmi, Inc. (2011) Summary page 2.

## Indications for use
The LINA Bipolar Loop is a 5mm bipolar electrosurgicol device intended for amputating the mobilized uterus during loparoscopic supracervical (subtotal) hysterectomy and resection of devasculated subserosol pedunculated myornas. To be used with an electrosurgical generator that provides a bipolar outlet

Source page: https://510kreport.com/device/K130305
Methodology: https://510kreport.com/methodology