← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

BSP — Needle, Conduction, Anesthetic (W/Wo Introducer)

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5150
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K243690PAJUNK GmbH Medizintechnologie · 510k2025-07-01
K243682PAJUNK GmbH Medizintechnologie · 510k2025-06-27
K250774PAJUNK GmbH Medizintechnologie · 510k2025-06-25
K243525PAJUNK GmbH Medizintechnologie · 510k2025-03-24
K241953PAJUNK GmbH Medizintechnologie · 510k2024-11-22

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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