# K102179: Enview (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 2200
- Decided: Dec 2, 2010 after 121 days
- Product code: OCV (Endoscope Holder)
- 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: 7 generations back to K931783 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093616: V. Mueller Camera Controller with Storage Cart, Carefusion 2200 (2009) Summary page 1.
- K090340: Freehand, Prosurgics Limited (2009) Summary page 1.

## Indications for use
The EnViewTM camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemnicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.

Source page: https://510kreport.com/device/K102179
Methodology: https://510kreport.com/methodology