Chrysalis Intelligence · Sponsors · Biopsybell S.R.L.

Biopsybell S.R.L.

Mirandola, IT · 2 510(k) clearances · 19 recalls

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Total clearances
2
2021-01-11 → 2023-10-30
Last 12 months
0
Product codes
2
Most recent
2023-10-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NDN Cement, Bone, Vertebroplasty Class II Orthopedic 1 2023-10-30
KNW Instrument, Biopsy Class II Gastroenterology, Urology 1 2021-01-11
Safety

Recalls (19)

Class I (serious)
0
Risk of injury / death
Total recalls
19
Currently ongoing
0
Most recent
2021-03-22
DateSeverityStatusRecall # ProductCodeReason
2021-03-22 Class II Terminated Z-1649-2021 10 GAUGE DRILL, CODE INTVM-DRL — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1648-2021 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1647-2021 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15 — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1646-2021 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1645-2021 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1644-2021 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1643-2021 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1642-2021 CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1641-2021 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1640-2021 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1639-2021 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1638-2021 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1637-2021 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1636-2021 EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1635-2021 CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1634-2021 BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111 — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1633-2021 BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1632-2021 RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US — Products labeled as sterile were distributed, but may not have been sterilized.
2021-03-22 Class II Terminated Z-1631-2021 BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system — Products labeled as sterile were distributed, but may not have been sterilized.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2023-10-30 K231340 Renova Spine Balloon Catheter NDN Class II Orthopedic
2021-01-11 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 KNW Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence