510(k) K010735
K010735 is an FDA 510(k) premarket notification submitted by Biopsybell S.A.S. for the device "SPEEDYBELL". The FDA issued a decision of Substantially Equivalent on August 17, 2001. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Biopsybell S.A.S. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2001
- Date Received
- March 12, 2001
- 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