Cleared Traditional

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

K203397 · Biopsybell S.R.L. · General & Plastic Surgery
Jan 2021
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K203397 is an FDA 510(k) clearance for the 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, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Biopsybell S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on January 11, 2021, 54 days after receiving the submission on November 18, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K203397 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2020
Decision Date January 11, 2021
Days to Decision 54 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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