Clearance Summary
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING received FDA 510(k) clearance under submission number K093899, sponsored by Ethicon Endo-Surgery, LLC. 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 2010-04-29.
- Submission: K093899
- Applicant / Sponsor: Ethicon Endo-Surgery, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2010-04-29
Classification & Regulation
This clearance is catalogued under FDA product code KNW and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.