# K141781: Kogent Spetzler Lighted Suction Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Katalyst Surgical, LLC
- Decided: Apr 9, 2015 after 281 days
- Product code: HBI (Illuminator, Fiberoptic, Surgical Field)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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 K113697 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113697: Eigr Surgical Illumination System, Invuity, Inc. (2012) Summary page 4.

## Indications for use
The Kogent™ Spetzler Lighted Suction Tubes are intended to provide surgical site illumination from a high intensity light source.

Source page: https://510kreport.com/device/K141781
Methodology: https://510kreport.com/methodology