# K051506: Mielo-Can, Best-Lisas, Ben - Bone Biopsy.  Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy

- Pathway: 510(k) (Traditional)
- Applicant: Sterylab S.R.L.
- Decided: Jul 27, 2005 after 50 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K871390 (1987). 18 ancestors in all.
18 later devices descend from it; 3 cite it directly.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980196: MD Tech Biopsy Set for Bone and Bone Marrow, Medical Device Technologies, Inc. (1998) Summary page 1.
- K974814: Manan (TM) Super-Core Biopsy Needles, Medical Device Technologies, Inc. (1998) Summary page 1.
- K990839: Tru-Core I Reusable Biopsy Instrument, Medical Device Technologies, Inc. (1999) Summary page 1.
- K980226: Manan Pro-Mag Automatic Biopsy System, Medical Device Technologies, Inc. (1998) Summary page 1.

## Most influential descendants
- K131157: Ranfac Bone Marrow Aspiration Needle (2013), 12 descendants of its own
- K140991: Ranfac Aspiration Needle with Adjustable Guide (2014), 5 descendants of its own
- K150563: Marrow Cellution Bone Marrow Aspiration Needle (2015), 4 descendants of its own
- K070759: Powered EZ-IO Pediatric Bone Marrow Aspiration System (2007), 3 descendants of its own
- K142377: The OnControl Bone Marrow Biopsy System by Vidacare (2014), 2 descendants of its own

## Indications for use
Bone and Bone marrow biopsy devices - Ben, Best Lisas, and Mielo-Can are indicated to harvest bone and / or bone marrow specimens. The pediatric bone marrow needle is intended for the purpose of obtaining access to the medullary cavities for the purpose of initiating resuscitative infusion or for aspirating marrow in pediatric patients. Soft Tissue Devices - Spring-Cut, Die-Cut, Fast-Gun and Colt are indicated to provide tissue samples of various soft organs and tissues, including, but not limited tO, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate, for diagnostic sampling of abnormalities. They are designed to provide tissue for histological examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographid'appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Source page: https://510kreport.com/device/K051506
Methodology: https://510kreport.com/methodology