# K050650: Novacyte Microendoscope and Accessories, Models NC1000;NCAM1000

- Pathway: 510(k) (Traditional)
- Applicant: Cytyc Surgical Products
- Decided: May 16, 2005 after 63 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 2 generations back to K932987 (1994). 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)
- K011189: Viaduct Microendoscope and Accessories, Acueity, Inc. (2001). Our reading of the summary gave K001189, FDA’s number for Modification to Convertors Surgical Gowns (Allegiance Healthcare Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acueity Microendoscope (Viaduct)”.
- K020310: Davlite Microendoscope & Accessories, Davlite Technologies (2002) Summary page 1.

## Indications for use
This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.

Source page: https://510kreport.com/device/K050650
Methodology: https://510kreport.com/methodology