510(k) K051158
K051158 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "ENCOR 7 GAUGE". The FDA issued a decision of Substantially Equivalent on May 16, 2005. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Senorx, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2005
- Date Received
- May 5, 2005
- Clearance Type
- Special
- 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