# K972497: Karl Storz Monopolar Coagulating Electrodes/ Karl Storz Monopolar Coagulating Needle Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Aug 27, 1997 after 55 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K073046: Ethicon Endo Surgery Articulating Needle Knife, Model 2504 (2008), 6 descendants of its own
- K082955: Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505 (2009), 2 descendants of its own
- K082114: Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00 (2008), 2 descendants of its own
- K103155: Sumo Access and Tissue Resection System (2011), 0 descendants of its own
- K093279: Navix Access Device (2010), 0 descendants of its own

## Indications for use
The Monopolar Coagulating Electrodes are indicated for use in cutting, coagulating, and/or fulgurating tissue during endoscopic general and plastic electrosurgical procedures.

Source page: https://510kreport.com/device/K972497
Methodology: https://510kreport.com/methodology