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)

MODIFICATION TO COLLAWOUND DRESSING

K-Number: K070269 · 2007-03-02

ApplicantCollamatrix Co., Inc.
Decision Date2007-03-02
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO COLLAWOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Collamatrix Co., Inc.. It received FDA 510(k) clearance on 2007-03-02 under 510(k) number K070269. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO COLLAWOUND DRESSING?

MODIFICATION TO COLLAWOUND DRESSING is a medical device that received FDA 510(k) clearance on 2007-03-02. The listed applicant is Collamatrix Co., Inc.. The 510(k) number is K070269.

When did MODIFICATION TO COLLAWOUND DRESSING receive FDA 510(k) clearance?

MODIFICATION TO COLLAWOUND DRESSING received FDA 510(k) clearance on 2007-03-02, under 510(k) number K070269.

Who is the listed applicant for MODIFICATION TO COLLAWOUND DRESSING?

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

What is the FDA product code for MODIFICATION TO COLLAWOUND DRESSING?

The FDA product code for MODIFICATION TO COLLAWOUND DRESSING is KGN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Collamatrix Co., 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.

K090894COLLAWOUND WOUND DRESSINGK071557COLLAWOUND HYDROGELK061474COLLAWOUND DRESSING

Related Devices (Code: KGN)

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.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, 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.

↑