# K080809: Iec Medsight and Medbright

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Endoscopy Components, LLC
- Decided: Aug 11, 2008 after 143 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K942817 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974391: Karl Storz Endovision XL Endoscopic Camera System, Karl Storz Imaging, Inc. (1998) Summary page 2.
- K983279: Endocam Camera Systems 5502 with Electronic CCD Endoscope, Richard Wolf Medical Instruments Corp. (1998) Summary page 2.
- K023659: 1-CCD Endocam 5520 System, Richard Wolf Medical Instruments Corp. (2003) Summary page 2.
- K003325: Ksi's New Camera Architecture (Nca) Video Imaging System, Karl Storz Imaging, Inc. (2001) Summary page 2.
- K983566: 3-Chip Video Camera, Stryker Endoscopy (1999) Summary page 2.
- K994090: Karl Storz Autoclavable Camera Head, Karl Storz Imaging, Inc. (2000) Summary page 2.
- K070266: 560 High Definition Camera System, Smith & Nephew, Inc. (2007) Summary page 2.
- K962595: Karl Storz Xenon 300 Light Source for Non-Flash Applications, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 2.
- K983628: Xenon Light Source Auto Lip 5123, Model 2123.011, Richard Wolf Medical Instruments Corp. (1998) Summary page 2.
- K905376: Storz S6000 Light Source, Storz Instrument Co. (1991) Summary page 2.

## Indications for use
The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes. MedSIGHT is a color, television camera system (supplies image) and MedBRIGHT is a xenon/halogen light source system (supplies light). Both can be used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) and it is designed for surgical procedures.

Source page: https://510kreport.com/device/K080809
Methodology: https://510kreport.com/methodology