Clearance Summary
BENDEREV PROTECT-A-PASS NEEDLE received FDA 510(k) clearance under submission number K921228, sponsored by Eimark Labs, 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 1992-09-14.
- Submission: K921228
- Applicant / Sponsor: Eimark Labs, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1992-09-14
Classification & Regulation
This clearance is catalogued under FDA product code KOA and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.