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

FDA 510(k)

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal

K-Number: K182259 · 2019-02-07

ApplicantAcell, Inc.
Decision Date2019-02-07
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is a medical device manufactured by Acell, Inc.. It received FDA 510(k) clearance on 2019-02-07 under approval number K182259. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal?

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is a medical device that received FDA 510(k) clearance on 2019-02-07. It is manufactured by Acell, Inc.. The 510(k) number is K182259.

When was Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal approved by the FDA?

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal received FDA 510(k) clearance on 2019-02-07, under approval number K182259.

What company makes Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal?

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is manufactured by Acell, Inc..

What is the FDA product code for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal?

The FDA product code for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is FTM.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT03164122 EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA COMPLETED NCT06073808 The Role of Amnion Membrane Allografts in Nipple Preservation NOT_YET_RECRUITING NCT06919809 Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery COMPLETED

Other Devices by Acell, Inc.

K162554Gentrix Surgical Matrix K153754MicroMatrix K172399MicroMatrix K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend K180776Cytal Wound Particulate K191734MatriStem UBM Pericardial Patch

View all 11 devices →

Related Devices (Code: FTM)

K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) K162554Gentrix Surgical MatrixAcell, Inc. K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTColorado Therapeutics, LLC K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)

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.

↑