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
FDA 510(k) clearance K203397 · decided 2021-01-11
Clearance details
- K-number
- K203397
- Device name
- 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
- Applicant
- Biopsybell S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-18
- Decision date
- 2021-01-11
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mirandola, IT
- Third-party review
- No
- Expedited review
- No
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|---|
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| EnCor EnCompass™ Breast Biopsy and Tissue Removal System (K252681) | Bard Peripheral Vascular, Inc. | 2025-12-12 |
| Resitu Slider 09 (RESL09) (K252183) | Resitu Medical AB | 2025-09-24 |
| Forcyte Autograft Harvest Kit (K243407) | Forcyte Medical, LLC | 2025-07-29 |
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Recalls involving this device
No recalls on record reference this clearance.