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FDA 510(k)

G4Derm / G4Derm Plus Synthetic Wound Matrix

K-Number: K222025 · 2023-10-11

ApplicantGel4med, Inc.
Decision Date2023-10-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

G4Derm / G4Derm Plus Synthetic Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Gel4med, Inc.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K222025. 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 G4Derm / G4Derm Plus Synthetic Wound Matrix?

G4Derm / G4Derm Plus Synthetic Wound Matrix is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Gel4med, Inc.. The 510(k) number is K222025.

When did G4Derm / G4Derm Plus Synthetic Wound Matrix receive FDA 510(k) clearance?

G4Derm / G4Derm Plus Synthetic Wound Matrix received FDA 510(k) clearance on 2023-10-11, under 510(k) number K222025.

Who is the listed applicant for G4Derm / G4Derm Plus Synthetic Wound Matrix?

The FDA 510(k) record lists Gel4med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G4Derm / G4Derm Plus Synthetic Wound Matrix?

The FDA product code for G4Derm / G4Derm Plus Synthetic Wound Matrix 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.

NCT06578650A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous NeoplasmsRECRUITINGNCT06616844IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot UlcersRECRUITINGNCT07632001Miro3D Wound Matrix for Treatment of Diabetic Foot UlcersRECRUITINGNCT07647705Borate-based Bioactive Glass Fiber Matrix (BBGFM) in the Treatment of Venus Leg Ulcers (VLU)NOT_YET_RECRUITINGNCT07701590CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUsRECRUITINGNCT07779239PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot UlcersNOT_YET_RECRUITING

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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