# K050356: Compression Anastomosis Ring (Car)

- Pathway: 510(k) (Traditional)
- Applicant: Niti Medical Technologies, Ltd.
- Decided: May 5, 2005 after 80 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: 11 generations back to K933887 (1993). 42 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033324: Compression Anastomosis Clip (Cac), Niti Medical Technologies, Ltd. (2004) Summary page 2.
- K041751: Compression Anastomosis Clip (Cac), Niti Medical Technologies, Ltd. (2004) Summary page 2.
- K043115: Laparoscopic Compression Anastomosis Clip (Lapcac), Niti Medical Technologies, Ltd. (2004) Summary page 2.
- K920752: Endopath Ils Endoscopic Circular Stapler, ETHICON, Inc. (1992) Summary page 2.
- K983536: Proximate Curved and Straight Intraluminal Staplers, Ethicon Endo-Surgery, Inc. (1998) Summary page 2.
- K024275: Auto Suture Premium Plus Ceea Disposable Stapler, United States Surgical, A Division of Tyco Healthc (2003) Summary page 2.

## Most influential descendants
- K062008: Endo Car Compression Anastomosis Ring (Car) (2006), 1 descendant of its own
- K093661: Colonring (2011), 0 descendants of its own

## Indications for use
The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of 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 Compression Anastomosis Ring is passed from the body.

Source page: https://510kreport.com/device/K050356
Methodology: https://510kreport.com/methodology