510(k) K220455
K220455 is an FDA 510(k) premarket notification submitted by Reshape Lifesciences for the device "Lap-Band System Calibration Tube". The FDA issued a decision of Substantially Equivalent on June 7, 2022. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Reshape Lifesciences has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2022
- Date Received
- February 17, 2022
- 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