Clearance Summary
OBSTI-HOOK received FDA 510(k) clearance under submission number K951148, sponsored by Onli. 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 1995-06-09.
- Submission: K951148
- Applicant / Sponsor: Onli
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1995-06-09
Classification & Regulation
This clearance is catalogued under FDA product code HGE and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.