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FDA 510(k)

Surgical Sutures with or without Needle

K-Number: K221767 · 2023-07-31

ApplicantHuaian Seamen Medical Technology Co., Ltd.
Decision Date2023-07-31
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Sutures with or without Needle is a medical device manufactured by Huaian Seamen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under approval number K221767. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Sutures with or without Needle?

Surgical Sutures with or without Needle is a medical device that received FDA 510(k) clearance on 2023-07-31. It is manufactured by Huaian Seamen Medical Technology Co., Ltd.. The 510(k) number is K221767.

When was Surgical Sutures with or without Needle approved by the FDA?

Surgical Sutures with or without Needle received FDA 510(k) clearance on 2023-07-31, under approval number K221767.

What company makes Surgical Sutures with or without Needle?

Surgical Sutures with or without Needle is manufactured by Huaian Seamen Medical Technology Co., Ltd..

What is the FDA product code for Surgical Sutures with or without Needle?

The FDA product code for Surgical Sutures with or without Needle is GAP.

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Related Devices (Code: GAP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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