# K971268: Bone & Marrow Cllection System

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical International Corp.
- Decided: Jul 3, 1997 after 87 days
- Product code: GEY (Motor, Surgical Instrument, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
To aseptically and efficiently collect osseous and marrow tissue during the drilling of skeletal structures. For the collection of autogenous bone and marrow tissues. For use with the BMCS Instrument Kit to facilitate implantation of autogenous bone and marrow tissue.

Source page: https://510kreport.com/device/K971268
Methodology: https://510kreport.com/methodology