Clearance Summary
NEEDLE HOLDER, MICROVASCULAR received FDA 510(k) clearance under submission number K771859, sponsored by Edward Weck, Inc.. 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 1977-10-04.
- Submission: K771859
- Applicant / Sponsor: Edward Weck, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1977-10-04
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.