# K130489: Electrode, Flexible Suction Coagulator

- Pathway: 510(k) (Special)
- Applicant: Optim, LLC
- Decided: Apr 19, 2013 after 53 days
- Product code: FEH (Electrode, Flexible Suction Coagulator)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K083275 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122593: Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2, Optim, LLC (2012) Summary page 1.
- K083275: Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2, Max Endoscopy, Inc. (2009) Summary page 1.

## Indications for use
The PRECISION Endloscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidloscope, or other flexible gastrointestinal endloscope.

Source page: https://510kreport.com/device/K130489
Methodology: https://510kreport.com/methodology