# K070315: Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8

- Pathway: 510(k) (Traditional)
- Applicant: Lina Medical Aps
- Decided: Oct 30, 2007 after 271 days
- Product code: KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K851958 (1985). 4 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981464: Omnitech Resectoscope Cutting Loop Electrode, Omnitech Systems, Inc. (1998) Summary page 1.
- K050294: Cook Ireland Sonnet Polypectomy Snare, Cook Ireland, Ltd. (2005) Summary page 1.

## Most influential descendants
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) (2011), 3 descendants of its own
- K122605: PKS Bill (2012), 1 descendant of its own
- K254303: Karl Storz Supraloop (2026), 0 descendants of its own
- K142525: PK Lap Loop (2014), 0 descendants of its own
- K132135: Lina Gold Loop HC (2014), 0 descendants of its own

## Recalls of this device
- Dec 1, 2009 · Not classified · Z-2688-2011: Potential for the LiNA Loop to break during operating procedure.
- Dec 1, 2009 · Not classified · Z-2689-2011: Potential for the LiNA Loop to break during operating procedure.
- Dec 1, 2009 · Not classified · Z-2690-2011: Potential for the LiNA Loop to break during operating procedure.

## Indications for use
The LiNA Loop is a 5mm monopolar electrosurgical device intended for cutting and removal of soft tissue in gynecological procedures involving endoscopic hysterectomy. It is used with standard electrosurgical generators.

Source page: https://510kreport.com/device/K070315
Methodology: https://510kreport.com/methodology