# K971114: Bioaccess Marrow Harvest System

- Pathway: 510(k) (Traditional)
- Applicant: Bioaccess, Inc.
- Decided: Jun 3, 1997 after 69 days
- Product code: GDM (Needle, Aspiration And Injection, Reusable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K843830 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953064: Bioaccess Marrow Harvest System, Bioaccess, Inc. (1995) Summary page 1.
- K843830: J -Jamshidi Type-Bone Marrow Biopsy/Aspi, Popper & Sons, Inc. (1984) Summary page 1.
- K895198: Hall Versipower Surgical Instrument System, Zimmer, Inc. (1989) Summary page 1.
- (no number) Jamshidi Aspiration needle: named in the summary without a submission number

## Indications for use
The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.

Source page: https://510kreport.com/device/K971114
Methodology: https://510kreport.com/methodology