510(k) K110883
K110883 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables for the device "J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA". The FDA issued a decision of Substantially Equivalent on June 8, 2011. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Busse Hospital Disposables has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2011
- Date Received
- March 30, 2011
- 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