510(k) K230474
K230474 is an FDA 510(k) premarket notification submitted by Palliare , Ltd. for the device "EVA5 Insufflator". The FDA issued a decision of Substantially Equivalent on March 24, 2023. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Palliare , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2023
- Date Received
- February 22, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Automatic Carbon-Dioxide For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type