COLONRING— 510(k) K093661

Substantially Equivalent

Niti Surgical Solutions, Ltd.

FDA 510(k) clearance K093661 for COLONRING, Substantially Equivalent on 2011-02-10. Applicant: Niti Surgical Solutions, Ltd..

Clearance details

Applicant: Niti Surgical Solutions, Ltd.
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 2009-11-25
Decision date: 2011-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.