14Fr Colon Decompression Set, Macon Colon Decompression Set— 510(k) K171619
Substantially EquivalentCook Ireland, Ltd.
FDA 510(k) clearance K171619 for 14Fr Colon Decompression Set, Macon Colon Decompression Set, Substantially Equivalent on 2017-08-01. Applicant: Cook Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cook Ireland, Ltd.
- Product code
- Code FEG
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Limerick, IE
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Adverse events under product code FEG
product code FEG- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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.