POZClass II

Biopsy Needle Kit

Gastroenterology, Urology · 21 CFR 876.1075

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.

MDR events1All time

Recalls1All time

Registered firms14Currently listed

510(k) clearances0All time

Recent MDR events

1 adverse event reports on file

KIT, NEEDLE, BIOPSYOct 18, 2017
Malfunction6958691

Event type breakdown

Malfunction1

Most-reported manufacturers

Recalls

1 recall events for this product code

ARROW INTERNATIONAL, LLC
Open, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2365-2026 · View FDA record ↗

Registered firms

14 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.