# K101458: Lina Xcise Model  Mor-1515

- Pathway: 510(k) (Traditional)
- Applicant: Lina Medical Aps
- Decided: Mar 11, 2011 after 289 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960640 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993801: Gynecare Laparoscopic Morcellator, ETHICON, Inc. (2000) Summary page 1.
- K960640: S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification), Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (1997) Summary page 1.

## Most influential descendants
- K243821: i-Cut (2025), 0 descendants of its own

## Indications for use
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy.

Source page: https://510kreport.com/device/K101458
Methodology: https://510kreport.com/methodology