Clearance Summary
MAGNETIC POINT GUARD FOR SURGICAL NEEDLES received FDA 510(k) clearance under submission number K920706, sponsored by Retrax. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1993-05-26.
- Submission: K920706
- Applicant / Sponsor: Retrax
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1993-05-26
Classification & Regulation
This clearance is catalogued under FDA product code FHQ and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.