# K093661: Colonring

- Pathway: 510(k) (Traditional)
- Applicant: Niti Surgical Solutions, Ltd.
- Decided: Feb 10, 2011 after 442 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K933887 (1993). 44 ancestors in all.
No later device cites it as a predicate yet.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062008: Endo Car Compression Anastomosis Ring (Car), Niti Medical Technologies, Ltd. (2006) Summary page 1.
- K050356: Compression Anastomosis Ring (Car), Niti Medical Technologies, Ltd. (2005) Summary page 1.

## Indications for use
The NiTi ColonRing™ device is intended for use throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses. in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi ColonRing™ is passed from the body.

Source page: https://510kreport.com/device/K093661
Methodology: https://510kreport.com/methodology