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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 a medical device manufactured by Synedgen, Inc.. It received FDA 510(k) clearance on 2018-02-21 under approval 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. It is manufactured by Synedgen, Inc.. The 510(k) number is K172338.

When was Catasyn Advanced Technology Wound Hydrogel approved by the FDA?

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

What company makes Catasyn Advanced Technology Wound Hydrogel?

Catasyn Advanced Technology Wound Hydrogel is manufactured by Synedgen, Inc..

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

NCT07613502 Bio Leg: Advancing Mobility NOT_YET_RECRUITING NCT07601997 Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (REFINE Study) NOT_YET_RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT06497309 Advanced Technology-based Rehabilitation Post-stroke Gait Re-learning COMPLETED NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT06326203 Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 39862365 Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies. Journal of medical systems (2025)

Other Devices by Synedgen, Inc.

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

Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

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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