510(k) K223890
K223890 is an FDA 510(k) premarket notification submitted by Chess Medical, Inc. for the device "NAJA Gastrointestinal Catheter". The FDA issued a decision of Substantially Equivalent on June 16, 2023. The device falls under product code FGD (Catheter, Retention, Barium Enema With Bag), a Class II device regulated under 21 CFR 876.5980.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2023
- Date Received
- December 27, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention, Barium Enema With Bag
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type