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)

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology

K-Number: K213125 · 2021-10-27

ApplicantSynovis Life Technologies. Inc. (A Subsidiary of Baxter
Decision Date2021-10-27
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is a medical device manufactured by Synovis Life Technologies. Inc. (A Subsidiary of Baxter. It received FDA 510(k) clearance on 2021-10-27 under approval number K213125. 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 PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is a medical device that received FDA 510(k) clearance on 2021-10-27. It is manufactured by Synovis Life Technologies. Inc. (A Subsidiary of Baxter. The 510(k) number is K213125.

When was PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology approved by the FDA?

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology received FDA 510(k) clearance on 2021-10-27, under approval number K213125.

What company makes PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is manufactured by Synovis Life Technologies. Inc. (A Subsidiary of Baxter.

What is the FDA product code for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

The FDA product code for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology 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 NCT07339020 Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy 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 NCT05081284 Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix ACTIVE_NOT_RECRUITING NCT07360691 Prospective Clinical Evaluation of High-Purity Type I Collagen in Select High-Risk Hernia Repair Scenarios COMPLETED

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.

↑