510(k) K171619
K171619 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "14Fr Colon Decompression Set, Macon Colon Decompression Set". The FDA issued a decision of Substantially Equivalent on August 1, 2017. The device falls under product code FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation), a Class II device regulated under 21 CFR 876.5980. Cook Ireland, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2017
- Date Received
- June 2, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type