Clearance Summary
WINGED NEEDLE HOLDER received FDA 510(k) clearance under submission number K974327, sponsored by Phx Technologies Corp.. 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 1998-01-09.
- Submission: K974327
- Applicant / Sponsor: Phx Technologies Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1998-01-09
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.