Clearance Summary
Spinal Manometer NRFit; Spinal Manometer LUER received FDA 510(k) clearance under submission number K170305, sponsored by PAJUNK GmbH Medizintechnologie. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-07-25.
- Submission: K170305
- Applicant / Sponsor: PAJUNK GmbH Medizintechnologie
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2500
- Decision date: 2017-07-25
Classification & Regulation
This clearance is catalogued under FDA product code FMJ and 21 CFR 880.2500, within the General Hospital review panel as a Class II device.