Who is the manufacturer of TX BIOPSY NEEDLE?

Gallini S.R.L. filed the 510(k) submission for TX BIOPSY NEEDLE (K962905).

What is the FDA product code for TX 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 TX BIOPSY NEEDLE?

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

Who can help prepare an FDA 510(k) submission like TX 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.

TX BIOPSY NEEDLE

K962905 · Gallini S.R.L. · FCG · Oct 11, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K962905
Device Name	TX BIOPSY NEEDLE
Applicant	Gallini S.R.L.
Product Code	FCG · Gastroenterology, Urology
Decision Date	Oct 11, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

Intended Use

This device is an automated, disposable and adjustable biopsy instrument designed for ultimate accuracy in obtaining high quality histological core samples, with three different choice of penetration depth and obtaining histological samples from 0.8 to 1.9 mm length.

Device Story

Automatic disposable biopsy needle; used for harvesting histological core samples from prostate, kidney, liver. Device features adjustable penetration depth; obtains samples 0.8 to 1.9 mm in length. Operated by clinicians in clinical settings to acquire tissue for diagnostic analysis. Benefit: provides high-quality core samples for histological examination.

Clinical Evidence

Bench testing only. Results: Gun firing test passed; Pyrogen test (LAL) passed. No clinical data provided.

Technological Characteristics

Automated, disposable, adjustable biopsy needle. Features three penetration depth settings. Biocompatibility of components verified by raw material suppliers.

Indications for Use

Indicated for obtaining histological core tissue samples from organs including prostate, kidney, and liver.

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

PRO-B Biopsy Needle (K951598)

Related Devices

K962969 — MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA · Medical Device Technologies, Inc. · Dec 6, 1996
K982960 — MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT · Medical Device Technologies, Inc. · Sep 23, 1998
K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES · Allegiance Healthcare Corp. · Jan 15, 2003
K203141 — Uramix CuraWay Biopsy Needle · Uramix, Inc. · Sep 17, 2021
K191472 — Biopsy Needle · Ushare Medical, Inc. · Jan 29, 2020

Submission Summary (Full Text)

{0} OCT 11 1996 Gallini K962905 # Summary of Safety and Effectiveness **Owner**: Gallini s.r.l. 88. Via S. Faustino 41037-Mirandola -Italy **Contact Person**: Caterina E. Galluzzo President, Gallini Intl. **Submission Date**: July 1996 **Device Name**: TX® Biopsy Needle **Predicate Device**: Promedical Ltd.. - PRO-B Biopsy Needle (510 (k) # K951598) **Description of Device function**: This device is an automatic disposable biopsy Needle developed for taking a range of tissue specimens, including those from the prostate, kidney and liver. **Intended Use**: This device is an automated, disposable and adjustable biopsy instrument designed for ultimate accuracy in obtaining high quality histological core samples, with three different choice of penetration depth and obtaining histological samples from 0.8 to 1.9 mm length. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The TX® Biopsy Needle is equivalent to the predicate devices in term of technological characteristics The following tests was performed to show the safety, efficacy and performance of the product. | TEST | RESULT | | --- | --- | | Gun Firing Test (TX/F/T) see attch. protocol Pyrogen Test (LAL) | passed passed | | All biocompatibility tests on the components are performed by the supplier of the row material. | | 88. Via S. Faustino - 41037 - Mirandola (MO) - Italy