Clearance Summary
VAN-TEC PROSTATE BIOPSY NEEDLE received FDA 510(k) clearance under submission number K870698, sponsored by Van-Tec, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1987-03-25.
- Submission: K870698
- Applicant / Sponsor: Van-Tec, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3920
- Decision date: 1987-03-25
Classification & Regulation
This clearance is catalogued under FDA product code KNN and 21 CFR 890.3920, within the Physical Medicine review panel as a Class I device.