Clearance Summary
Biopsy Forceps received FDA 510(k) clearance under submission number K170726, sponsored by Fehling Instruments GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-06-02.
- Submission: K170726
- Applicant / Sponsor: Fehling Instruments GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4075
- Decision date: 2017-06-02
Classification & Regulation
This clearance is catalogued under FDA product code DWZ and 21 CFR 870.4075, within the Cardiovascular review panel as a Class II device.