Search Results
Found 1 results
510(k) Data Aggregation
K Number
K093661Device Name
COLONRING
Manufacturer
Date Cleared
2011-02-10
(442 days)
Product Code
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
NITI SURGICAL SOLUTIONS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NiTi ColonRing™ device is intended for use throughout the alimentary tract for endto-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.
Device Description
The ColonRing™ device is a sterile single use device. The ColonRing™ provides a simple method for the creation circular compression anastomosis of the alimentary tract. After a period of 7-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.
Ask a Question
Ask a specific question about this device
Page 1 of 1