Sterile Surgical Catgut and Similar Sterile Suture Materials

Absorbable surgical sutures are generally regulated as Class II medical devices requiring 510(k) premarket notification clearance from FDA's Center for Devices and Radiological Health (CDRH). The foreign manufacturer must hold an active FDA device establishment registration, and the specific suture product must have a cleared 510(k). Shipments from establishments without active registration are subject to refusal of admission. Consult a licensed customs broker and verify CDRH clearance status before importation.

Heading 300610 (line 3006100100) is reserved for suture materials that are sterile and presented in a form suitable for surgical use. Non-sterile suture thread or bulk suture materials not put up for surgical use are classified in textile chapters based on fiber composition. The sterile, surgical-use presentation — typically individual sterile packaging — is the key criterion that places a product in Chapter 30 rather than in textile or other chapters.