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FDA 510(k)

Catasyn Advanced Technology Wound Hydrogel

K-Number: K172338 · 2018-02-21

ApplicantSynedgen, Inc.
Decision Date2018-02-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Catasyn Advanced Technology Wound Hydrogel is the device name listed in this FDA 510(k) record. The listed applicant is Synedgen, Inc.. It received FDA 510(k) clearance on 2018-02-21 under 510(k) number K172338. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catasyn Advanced Technology Wound Hydrogel?

Catasyn Advanced Technology Wound Hydrogel is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is Synedgen, Inc.. The 510(k) number is K172338.

When did Catasyn Advanced Technology Wound Hydrogel receive FDA 510(k) clearance?

Catasyn Advanced Technology Wound Hydrogel received FDA 510(k) clearance on 2018-02-21, under 510(k) number K172338.

Who is the listed applicant for Catasyn Advanced Technology Wound Hydrogel?

The FDA 510(k) record lists Synedgen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Catasyn Advanced Technology Wound Hydrogel?

The FDA product code for Catasyn Advanced Technology Wound Hydrogel is FRO. This falls under the Anesthesiology category.

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.

NCT07185191Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)RECRUITINGNCT07541196PAW-Hydrogel for Chronic Wound HealingRECRUITINGNCT07779239PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot UlcersNOT_YET_RECRUITING

Other records listing Synedgen, Inc. 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.

K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse

Related Devices (Code: FRO)

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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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