BIOMID BONE MARROW BIOPSY NEEDLE
Device Facts
| Record ID | K962569 |
|---|---|
| Device Name | BIOMID BONE MARROW BIOPSY NEEDLE |
| Applicant | Gallini Intl., Inc. |
| Product Code | FCG · Gastroenterology, Urology |
| Decision Date | Nov 27, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
Intended Use
The device is intended to be used for drawing osteomedullary substances and/or the explantation of bone marrow.
Device Story
BIOMID® Bone Marrow Biopsy Needle; manually operated device; used for aspiration or explantation of bony substance/bone marrow. Clinician-operated in clinical settings. Provides physical access to bone marrow for diagnostic sampling. Benefits patient by enabling minimally invasive collection of marrow for pathological analysis.
Clinical Evidence
Bench testing only. Biocompatibility testing performed: intracutaneous reactivity, acute systemic toxicity, pyrogen test, and cytotoxicity; all tests passed.
Technological Characteristics
Manually operated biopsy needle; Jamshidi-style design; intended for bone marrow aspiration/explantation. Biocompatible materials verified via ISO/standard toxicity testing.
Indications for Use
Indicated for patients requiring bone marrow aspiration or biopsy for the collection of osteomedullary substances.
Regulatory Classification
Identification
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Predicate Devices
- Promedical - Jamshidi style biopsy needle
Related Devices
- K962570 — ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE · Gallini Intl., Inc. · Nov 27, 1996
- K962568 — ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES · Gallini Intl., Inc. · Nov 25, 1996
- K192099 — MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System · Medax Srl Unipersonale · Apr 2, 2020
- K020987 — BMN I TYPE MARROW ASPIRATION NEEDLE · H.S. Hospital Service S.R.L. · Jun 25, 2002
- K961959 — MD TECH BIOPSY SET FOR BONE AND BONE MARROW · Medical Device Technologies, Inc. · Jul 19, 1996
