TZ
Device Facts
| Record ID | K964777 |
|---|---|
| Device Name | TZ |
| Applicant | Gallini Intl., Inc. |
| Product Code | KNW · Gastroenterology, Urology |
| Decision Date | Jan 3, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
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.
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.
Indications for Use
Indicated for patients requiring histological core samples from soft tissues, including liver, kidney, and prostate.
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 Ltd. - PRO-B Biopsy Needle (K951598)
Related Devices
- K034021 — VACUUM ASSISTED CORE BIOPSY DEVICE · Suros Surgical Systems, Inc. · Sep 8, 2004
- K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES · Allegiance Healthcare Corp. · Jan 15, 2003
- K962905 — TX BIOPSY NEEDLE · Gallini S.R.L. · Oct 11, 1996
- K013069 — BIOSPEED · H.S. Hospital Services S.P.A. · Dec 12, 2001
- K962077 — BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER · C.R. Bard, Inc. · Jul 30, 1996
