Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set— 510(k) K152524

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K152524 for Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set, Substantially Equivalent on 2015-09-30. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2015-09-03
Decision date: 2015-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.