510(k) K193325
K193325 is an FDA 510(k) premarket notification submitted by Prosys International, Ltd. for the device "Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches". The FDA issued a decision of Substantially Equivalent on Mar 13, 2020. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 13, 2020
- Date Received
- Dec 2, 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
- 510(k)