Biopsy Needle Kit
FDA product code POZ · Class II (moderate risk) · 21 CFR 876.1075 · Gastroenterology, Urology
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
0510(k) clearances
0PMA approvals
1recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2365-2026 Class I | Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |