510(k) K970565
K970565 is an FDA 510(k) premarket notification submitted by Biopsys Medical, Inc. for the device "MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)". The FDA issued a decision of Substantially Equivalent on March 28, 1997. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Biopsys Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1997
- Date Received
- February 13, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type