# Biopsybell S.R.L.

- Location (FDA's records): Mirandola, IT
- FDA decisions: 7 (2001–2023): 7 510(k) clearances
- Names in FDA's records: Biopsybell S.R.L. (4); Biopsybell S.A.S. (3)
- Product codes: KNW (4), NDN (1), HRX (1), FCG (1)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ranfac, Corp.: 1 (https://510kreport.com/company/ranfac)
- Bauer Medical, Inc.: 1 (https://510kreport.com/company/bauer-medical)
- Pan Medical, Ltd.: 1 (https://510kreport.com/company/pan-medical)
- Gallini Medical Devices, Srl: 1 (https://510kreport.com/company/gallini-medical-devices)
- Stryker Instruments: 1 (https://510kreport.com/company/stryker-instruments)

## Firms that cite its devices most
- Moller Medical GmbH: 2 (https://510kreport.com/company/moller-medical)
- Medax Srl Unipersonale: 1 (https://510kreport.com/company/medax-unipersonale)
- Itp Innovative Tomography Products GmbH: 1 (https://510kreport.com/company/itp-innovative-tomography-products)
- Somatex Medical Technologies GmbH: 1 (https://510kreport.com/company/somatex-medical-technologies)

## Its most-cited devices
- K130616: Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-Needles (2014), cited by 4
- K010735: Speedybell (2001), cited by 3
- K011104: Osteobell (2001), cited by 1

## Recent decisions
- K231340: Renova Spine Balloon Catheter (Oct 30, 2023)
- K203397: 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 (Jan 11, 2021)
- K180315: Diskom (Mar 26, 2018)
- K130616: Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-Needles (Feb 7, 2014)
- K010735: Speedybell (Aug 17, 2001)
- K011075: Easybell (Jun 27, 2001)
- K011104: Osteobell (May 31, 2001)

Source page: https://510kreport.com/company/biopsybell