510(k) K190114
K190114 is an FDA 510(k) premarket notification submitted by Convatec Limited for the device "Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)". The FDA issued a decision of Substantially Equivalent on April 30, 2019. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Convatec Limited has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2019
- Date Received
- January 24, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type