DeviceClearance

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— 510(k) K203397

Substantially Equivalent

Biopsybell S.R.L.

FDA 510(k) clearance K203397 for 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, Substantially Equivalent on 2021-01-11. Applicant: Biopsybell S.R.L.. Device class: 2.

Clearance details

Applicant
Biopsybell S.R.L.
Product code
Code KNW
Device class
Class 2
Regulation
21 CFR 876.1075
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mirandola, IT
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KNW

product code KNW
Death
9
Injury
965
Malfunction
10,444
Other
3
Total
11,421

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.