# K981464: Omnitech Resectoscope Cutting Loop Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Omnitech Systems, Inc.
- Decided: Jul 10, 1998 after 78 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
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070315: Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8 (2007), 7 descendants of its own
- 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

## Indications for use
The Omnitech Resectoscope Cutting Loop Electrode Device is indicated for resection/coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.

Source page: https://510kreport.com/device/K981464
Methodology: https://510kreport.com/methodology