510(k) K203397
K203397 is an FDA 510(k) premarket notification submitted by Biopsybell S.R.L. for the device "Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm". The FDA issued a decision of Substantially Equivalent on January 11, 2021. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Biopsybell S.R.L. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2021
- Date Received
- November 18, 2020
- 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