Clearance Summary
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G received FDA 510(k) clearance under submission number K983897, sponsored by Ri Mos. S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1999-02-01.
- Submission: K983897
- Applicant / Sponsor: Ri Mos. S.R.L.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5100
- Decision date: 1999-02-01
Classification & Regulation
This clearance is catalogued under FDA product code HEE and 21 CFR 884.5100, within the Obstetrics/Gynecology review panel as a Class II device.