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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 the device name listed in this FDA 510(k) record. The listed applicant is Huaian Seamen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under 510(k) 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. The listed applicant is Huaian Seamen Medical Technology Co., Ltd.. The 510(k) number is K221767.

When did Surgical Sutures with or without Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for Surgical Sutures with or without Needle?

The FDA 510(k) record lists Huaian Seamen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: GAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241486Sofsilk™ Coated Braided Silk SutureCovidienK222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.K162396SILK Surgical SutureTeleflexmedical, Inc.

Official Source

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

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