Tubular Metal Needles & Needles for Sutures, Parts & Accessories

Finished suture assemblies — needle and thread combined — are generally classified as sutures rather than as needles alone, and may fall under a different heading in Chapter 30 or Chapter 90 depending on the material and configuration. The needle-only heading (9018320000) applies when needles are imported separately as components or accessories. Importers of pre-assembled suture products should seek a binding ruling from CBP to confirm the correct classification.

For customs purposes, the key distinctions are whether the needle is tubular (hollow, for injection or aspiration) versus solid (for suturing), and whether it is imported as a finished device or as a part. For procurement, gauge (needle diameter per ISO or ASTM standards), bevel type, and stainless steel alloy grade are the primary specifications that affect both clinical performance and FDA device classification. Importers should ensure foreign manufacturers maintain ISO 13485 quality management certification as part of supplier qualification.