510(k) K230206
K230206 is an FDA 510(k) premarket notification submitted by Gravitas Medical, Inc. for the device "Entarik Feeding Tube System; Entarik Feeding Tube". The FDA issued a decision of Substantially Equivalent on March 24, 2023. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Gravitas Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2023
- Date Received
- January 25, 2023
- 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