BIOMOL ASPIRATION BIOPSY NEEDLE
Device Facts
| Record ID | K002947 |
|---|---|
| Device Name | BIOMOL ASPIRATION BIOPSY NEEDLE |
| Applicant | H.S. Hospital Service S.R.L. |
| Product Code | FCG · Gastroenterology, Urology |
| Decision Date | Dec 19, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
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.
