← Product Code [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW) · K964777

# TZ (K964777)

_Gallini Intl., Inc. · KNW · Jan 3, 1997 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K964777

## Device Facts

- **Applicant:** Gallini Intl., Inc.
- **Product Code:** [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW.md)
- **Decision Date:** Jan 3, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1075
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

This device is intended to be used to take high quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.

## Device Story

Spring-loaded, disposable biopsy needle; used to obtain histological core samples from soft tissues (liver, kidney, prostate). Operated by clinicians in clinical settings. Device mechanism involves spring-loaded action to capture tissue samples. Output is a physical tissue core for diagnostic analysis.

## Clinical Evidence

Bench testing only. Firing test passed; pyrogen test (LAL) passed; biocompatibility testing performed by raw material suppliers.

## Technological Characteristics

Spring-loaded, disposable biopsy needle. Biocompatible materials used per supplier certification.

## 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 Ltd. - 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}

GALLINI
Medical Products and Services
K964777
Jan 3, 1997

# 510(K) SUMMARY

|  OWNER: | Gallini s.r.l.
88/90 Via S. Faustino
41037-Mirandola (MO) Italy  |
| --- | --- |
|  CONTACT PERSON: | Paul L. Hawthorne
U.S. Representative  |
|  SUBMISSION DATE: | November 22, 1996  |
|  DEVICE NAME: | “TZ®” Biopsy Needle  |
|  PREDICATE DEVICE: | ProMedical Ltd. - PRO-B Biopsy Needle
510(K)# - K951598  |
|  DESCRIPTION OF DEVICE FUNCTION: | The device is a spring loaded, disposable biopsy needle.  |
|  INTENDED USE: | This device is intended to be used to take high quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.  |

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The “TZ®” Biopsy needle is identical to the predicate devices in terms of technological characteristics.

The following tests were performed to demonstrate the safety and efficacy of the device.

|  TEST | RESULT  |
| --- | --- |
|  Firing Test | Passed  |
|  Pyrogen Test (LAL) | Passed  |
|  Biocompatibility | All tests are performed by the raw material suppliers.  |

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. - Rec. Soc. Trib. di Modena n. 31718 - C.C.I.A.A. di Modena N. 226177 - P. IVA: 01935440360 - Cod. Fisc.: 01281650174

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K964777](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K964777)

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