Clearance Summary
NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 received FDA 510(k) clearance under submission number K083667, sponsored by B-K Medical Aps. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-02-02.
- Submission: K083667
- Applicant / Sponsor: B-K Medical Aps
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2009-02-02
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.