Who is the manufacturer of ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE?

Gallini Intl., Inc. filed the 510(k) submission for ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE (K962570).

What is the FDA product code for ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE?

FCG. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE

Q: What are the predicate devices for ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE?

Promedical - Jamshidi style biopsy needle.

K962570 · Gallini Intl., Inc. · FCG · Nov 27, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K962570
Device Name	ISAN STERNAL-ILIAC ASPIRATION 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 from the sternum or from the iliac crest.

Device Story

Manually operated biopsy needle; used for aspiration or explantation of bony substance from sternum or iliac crest. Operated by clinicians in clinical settings. Provides bone marrow samples for diagnostic evaluation. Benefits patient by enabling minimally invasive access to bone marrow for clinical decision-making.

Clinical Evidence

Bench testing only. Biocompatibility testing performed: Intracutaneous Reactivity (passed), Acute Systemic Toxicity (passed), Pyrogen Test (passed), and Cytotoxicity (passed).

Technological Characteristics

Manually operated biopsy needle; stainless steel construction (implied by device type); sterile; single-use; form factor designed for sternal/iliac crest access.

Indications for Use

Indicated for aspiration or biopsy of osteomedullary substances from the sternum or iliac crest in patients requiring bone marrow sampling.

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

K962568 — ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES · Gallini Intl., Inc. · Nov 25, 1996
K962569 — BIOMID BONE MARROW BIOPSY NEEDLE · Gallini Intl., Inc. · Nov 27, 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
K980068 — WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE · Worldwide Medical Technologies, LLC · Jan 23, 1998
K242322 — Bone Marrow Biopsy Needle · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 24, 2025

Submission Summary (Full Text)

{0} NOV 27 1996 GALINI Medical Products and Services K962570 # 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:** ISAN®-Sternal-Iliac Crest Aspiration-Biopsy Needle **PREDICATE DEVICE:** Promedical - Jamshidi style biopsy needle **INTENDED USE:** The device is intended to be used for drawing osteomedullary substances from the sternum or from the iliac crest. **DESCRIPTION OF FUNCTION:** A manually operated biopsy needle used for aspiration or explantation of bony substance. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The ISAN® 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 | Gallini S.r.l. - Via S. Faustino, 88 - 41037 MIRANDOLA (MO) ITALY - Tel. 0535/21983 - Fax 0535/24184 Cap. Soc. Lit. 198.000.000 i.v. - Reg. Soc. Trib. di Modena n. 31718 - C.C.I.A.A. di Modena N. 226177 - P. IVA: 01935440360 - Cod. Fisc.: 01281650174