Cook ECM Powder— 510(k) K152033

Substantially Equivalent

Cook Biotech Incorporated

FDA 510(k) clearance K152033 for Cook ECM Powder, Substantially Equivalent on 2015-08-19. Applicant: Cook Biotech Incorporated.

Clearance details

Applicant: Cook Biotech Incorporated
Product code: Code KGN
Advisory panel: Unknown
Date received: 2015-07-22
Decision date: 2015-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.