Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set— 510(k) K182832

Unknown

Cook Incorporated

FDA 510(k) clearance K182832 for Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set, Unknown on 2019-06-26. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code KGC
Advisory panel: Gastroenterology, Urology
Date received: 2018-10-09
Decision date: 2019-06-26
Decision: Unknown
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGC

product code KGC

Death: 7
Total: 7

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.