510(k) K944252
K944252 is an FDA 510(k) premarket notification submitted by Biopsys Medical, Inc. for the device "BIOPSY DEVICE ACCESSORY". The FDA issued a decision of Substantially Equivalent on Dec 5, 1994. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. Biopsys Medical, Inc. has 14 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 5, 1994
- Date Received
- Aug 30, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy, Suction
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type
- 510(k)