# K083275: Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2

- Pathway: 510(k) (Traditional)
- Applicant: Max Endoscopy, Inc.
- Decided: Jun 9, 2009 after 215 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122593: Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2 (2012), 1 descendant of its own
- K130489: Electrode, Flexible Suction Coagulator (2013), 0 descendants of its own

## Indications for use
The PRECISION Endoscopic Infrared Coagulator (model 5100) with single-use disposable MAXi-guide flexible light guide (model 5100-240-3.2) is intended for treatment of hemorrhoids by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

Source page: https://510kreport.com/device/K083275
Methodology: https://510kreport.com/methodology