# K070376: Conmed Linvatec 300W Xenon Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Linvatec
- Decided: Aug 20, 2007 after 193 days
- Product code: GCT (Light Source, Endoscope, Xenon Arc)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962595 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031994: Linvatec 300W Xenon Light Source, Linvatec Corp. (2003) Summary page 2.
- K962595: Karl Storz Xenon 300 Light Source for Non-Flash Applications, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 2.

## Recalls of this device
- May 20, 2011 · Class II · Z-2455-2012: Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to 
- May 20, 2011 · Class II · Z-2456-2012: Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to 

## Indications for use
The ConMed Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

Source page: https://510kreport.com/device/K070376
Methodology: https://510kreport.com/methodology