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HS Code for Surgical Sutures

The HS Code for surgical sutures is 300610. The MFN duty rate for importing to the US is Free.

HS Code (6-digit)300610
US Duty Rate (MFN)Free
EU Duty Rate (MFN)0%
Chapter30
Heading3006
Last Updated2026-05
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Description

Sterile surgical catgut and similar sterile suture materials

HS Code 300610 covers sterile surgical catgut and similar sterile suture materials with a US MFN duty rate of Free.

Frequently Asked Questions

What specific customs risks are associated with importing sutures classified under 300610?

The primary risk is detention for lack of proper U.S. FDA clearance, as sterile surgical sutures are Class II or III medical devices requiring pre-market notification [510(k)] or approval. Shipments are also frequently examined for sterility validation and to verify that the packaging and labeling comply with FDA regulations, which can cause significant delays if not in perfect order.

What are the key cost factors beyond the product price when importing sterile surgical catgut (HTS 300610)?

Key additional costs include a 0% US MFN duty rate, but you must pay the 0.3464% FDA user fee for medical devices (FY 2024 rate). For shipments requiring formal entry (value over $2500), you will also incur Merchandise Processing Fees (MPF) of 0.3464% (minimum $27.23, maximum $614.35).

Compliance Notes for Surgical Sutures (300610)

Surgical sutures classifiable under 300610 must be sterile and presented in measured lengths or put up for retail sale for surgical use. Non-sterile sutures, including raw materials like monofilaments on spools, are excluded and typically classified in Chapter 39 or 54. Importers must be prepared to provide documentation, such as a Free Sale Certificate or Certificate of Manufacturing, to prove medical device status to U.S. Customs and Border Protection (CBP) and the FDA. Sutures may also be subject to FDA's 510(k) premarket notification requirements, and their packaging must clearly indicate sterility and intended use to avoid reclassification or detention.

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Data sourced from USITC Harmonized Tariff Schedule 2026. Last updated: 2026-05.

This tool is for informational purposes only. Consult a licensed customs broker for official classification and binding rulings.