# K213610: Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Katalyst Surgical, LLC
- Decided: Oct 7, 2022 after 326 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
Longest line of descent: 5 generations back to K884656 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110924: Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps, Synergetics, Inc. (2011) Summary page 5.
- K160103: Spetzler Malis Dual Illuminating Bipolar Forceps, Synergetics (2016) Summary page 5.
- K123172: Kogent Bipolar Forceps, Katalyst Surgical, LLC (2012) Summary page 5.

## Indications for use
The Kogent Disposable Copper Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Copper Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue. The Kogent Disposable Copper Illuminating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and to supply light for surgical procedures.

Source page: https://510kreport.com/device/K213610
Methodology: https://510kreport.com/methodology