510(k) K112342
K112342 is an FDA 510(k) premarket notification submitted by Convatec, Inc. for the device "FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 2012. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Convatec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2012
- Date Received
- August 15, 2011
- 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