← Product Code [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG) · K962569

# BIOMID BONE MARROW BIOPSY NEEDLE (K962569)

_Gallini Intl., Inc. · FCG · Nov 27, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K962569

## Device Facts

- **Applicant:** Gallini Intl., Inc.
- **Product Code:** [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG.md)
- **Decision Date:** Nov 27, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1075
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## 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.

## Regulatory 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

## Submission Summary (Full Text)

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{0}

NOV 27 1996
GALLINI
Medical Products and Services
K 962569

# SUMMARY OF SAFETY AND EFFECTIVENESS

**OWNER:**
Gallini s.r.l.
88/90 Via S. Faustino
Mirandola, Italy
41037

**CONTACT:**
Paul L. Hawthorne
U.S. Representative
C/O Coeurage Enterprises
3106 Bretton Court
Glen Allen,VA 23060

**SUBMISSION DATE:** April, 1996

**DEVICE NAME:** BIOMID® - Bone Marrow Biopsy Needle

**PREDICATE DEVICE:** Promedical - Jamshidi style biopsy needle

**INTENDED USE:** The device is intended to be used for drawing osteomedullary substances and/or the explantation of bone marrow.

**DESCRIPTION OF FUNCTION:** A manually operated biopsy needle used for aspiration or explantation of bony substance.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The ACRI® needle is equivalent to the predicate device in terms of technological characteristics and function.

The following tests were performed to demonstrate the safety, performance and efficacy of the product;

|  TEST | RESULT  |
| --- | --- |
|  Intracutaneous Reactivity | Passed  |
|  Acute Systemic Toxicity | Passed  |
|  Pyrogen Test | Passed  |
|  Cytotoxicity | Passed  |

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K962569](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K962569)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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