← Product Code [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG) · K962905

# TX BIOPSY NEEDLE (K962905)

_Gallini S.R.L. · FCG · Oct 11, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K962905

## Device Facts

- **Applicant:** Gallini S.R.L.
- **Product Code:** [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG.md)
- **Decision Date:** Oct 11, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1075
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## 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.

## 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

- PRO-B Biopsy Needle ([K951598](/device/K951598.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
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{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

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K962905](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K962905)

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