# K122593: Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2

- Pathway: 510(k) (Special)
- Applicant: Optim, LLC
- Decided: Sep 13, 2012 after 20 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: 1 generation back to K083275 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K130489: Electrode, Flexible Suction Coagulator (2013), 0 descendants of its own

## 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 endoscope.

Source page: https://510kreport.com/device/K122593
Methodology: https://510kreport.com/methodology