# K130616: Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-Needles

- Pathway: 510(k) (Traditional)
- Applicant: Biopsybell S.R.L.
- Decided: Feb 7, 2014 after 337 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960064 (1996). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011104: Osteobell, Biopsybell S.A.S. (2001) Summary page 12.
- K010735: Speedybell, Biopsybell S.A.S. (2001) Summary page 13.
- K960064: Temno Achieve Biopsy Needle, Bauer Medical, Inc. (1996) Summary page 14.

## Most influential descendants
- K222462: Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) (2023), 1 descendant of its own
- K172344: Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) (2017), 1 descendant of its own
- K162588: Möller Medical Biopsy Needles and Systems (2017), 1 descendant of its own
- K242128: Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (2025), 0 descendants of its own
- K233294: Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM (2024), 0 descendants of its own

## Recalls of this device
- Mar 25, 2021 · Class II · Z-1700-2021: Products distributed as sterile may not have been adequately sterilized
- Mar 22, 2021 · Class II · Z-1634-2021: Products labeled as sterile were distributed, but may not have been sterilized.

## Indications for use
- OSThOBELL 'T': Needle for bone-marrow biopsy - ORION: Needle for bone-marrow biopsy - ILIAC-MARROW: Needle for bone-marrow biopsy - OBSTERN: Needle for bone-marrow biopsy - STERLNOBELL: Needle for bone-marrow biopsy - TOTALLY REMOVE; Needle for bone-marrow biopsy - UNLUX SYSTEM: Needle for bone-marrow biopsy - OSTEOBELL EXPLANT: Needle for bone-marrow explant - ORION EXPLANT: Needle for bone-marrow explant - ILIAC-MARROW EXPLANT: Needle for bone-marrow explant - OBSTERN EXPLANT: Needle for bone-marrow explant - STERNOBELL EXPLANT: Needle for bone-marrow explant - SPEEDYBELL: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS BREAST, KIDNEY, LIVER, PROSTATE) - SPEEDYBELL & INTRODUTTORE: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS BREAST, KIDNEY, LIVER, PROSTATE) - SPEEDYBELL DOPPIA CORSA: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS BREAST, KIDNEY, LIVER, PROSTATE) - SPEEDYBELL DOPPIA CORSA & INTRODUTTORE: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS BREAST, KIDNEY, LIVER, PROSTATE) - ESTER: AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS LIVER) - ESTER & INTRODUTTORE: AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY (SUCH AS LIVER)

Source page: https://510kreport.com/device/K130616
Methodology: https://510kreport.com/methodology