Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Non absorbable Surgical Polypropylene Suture

K-Number: K230746 · 2023-09-14

ApplicantShandong Haidike Medical Products Co., Ltd.
Decision Date2023-09-14
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Non absorbable Surgical Polypropylene Suture is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Haidike Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K230746. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Non absorbable Surgical Polypropylene Suture?

Non absorbable Surgical Polypropylene Suture is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Shandong Haidike Medical Products Co., Ltd.. The 510(k) number is K230746.

When did Non absorbable Surgical Polypropylene Suture receive FDA 510(k) clearance?

Non absorbable Surgical Polypropylene Suture received FDA 510(k) clearance on 2023-09-14, under 510(k) number K230746.

Who is the listed applicant for Non absorbable Surgical Polypropylene Suture?

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

What is the FDA product code for Non absorbable Surgical Polypropylene Suture?

The FDA product code for Non absorbable Surgical Polypropylene Suture is GAW.

Related Clinical Trials

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.

NCT06511414Effect of Duramesh™ on Hernia Formation After Ileostomy ClosureACTIVE_NOT_RECRUITINGNCT07639372A Self-Controlled Clinical Study of Fast-Absorbable Versus Slow-Absorbable Sutures Applied in Ultra Tension-Reducing Suture TechniqueRECRUITING

Other records listing Shandong Haidike Medical Products Co., Ltd. as applicant

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.

K231183Non absorbable Surgical Polyester SutureK210518Surgical Face Mask

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLCK193530Deklene MAXXTeleflex Medical

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.

↑