# K121343: Modulap Loop

- Pathway: 510(k) (Traditional)
- Applicant: Atc Technologies, Inc.
- Decided: Jun 14, 2013 after 406 days
- Product code: KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K851958 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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)

## Indications for use
The Modulap Loop is intended for monopolar electrosurgical coagulation/cutting during laparoscopic surgery. It is indicated for the amputation of the uterus during supracervical hysterectomy and for resection of pedunculated subserosal (abdominal) myomas. It is not intended for use in hysteroscopy or for contraceptive coagulation of the fallopian tubes.

Source page: https://510kreport.com/device/K121343
Methodology: https://510kreport.com/methodology