ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES
Device Facts
| Record ID | K962568 |
|---|---|
| Device Name | ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES |
| Applicant | Gallini Intl., Inc. |
| Product Code | FCG · Gastroenterology, Urology |
| Decision Date | Nov 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
Indications for Use
The device is intended to be used for drawing osteomedullary substances from the iliac crest.
Device Story
Manually operated biopsy needle; used for aspiration or explantation of bony substance from iliac crest. Operated by clinician; provides physical access to bone marrow/tissue. Benefits patient by enabling diagnostic sampling of osteomedullary material.
Clinical Evidence
Bench testing only. Biocompatibility testing performed: Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Test, and Cytotoxicity; all tests passed.
Technological Characteristics
Manually operated biopsy needle for bone aspiration. Materials and specific dimensions not provided. Non-powered, mechanical device.
Indications for Use
Indicated for patients requiring aspiration or biopsy of osteomedullary substances from the iliac crest.
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
