# K254303: Karl Storz Supraloop

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Sep 24, 2026 after 267 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) Summary page 5.

## Indications for use
The KARL STORZ SUPRALOOP is a monopolar electrosurgical device intended for cutting and removal of soft tissue in gynecological procedures involving endoscopic hysterectomy in adult women. It is used with standard electrosurgical generators

Source page: https://510kreport.com/device/K254303
Methodology: https://510kreport.com/methodology