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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 the device name listed in this FDA 510(k) record. The listed applicant is Synovis Life Technologies. Inc. (A Subsidiary of Baxter. It received FDA 510(k) clearance on 2021-10-27 under 510(k) 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. The listed applicant is Synovis Life Technologies. Inc. (A Subsidiary of Baxter. The 510(k) number is K213125.

When did PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology receive FDA 510(k) clearance?

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

Who is the listed applicant for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

The FDA 510(k) record lists Synovis Life Technologies. Inc. (A Subsidiary of Baxter as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07339020Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve GastrectomyCOMPLETEDNCT07351071Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal ResectionsRECRUITINGNCT07495254Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Exercise and Health Education in Lateral Elbow TendinopathyNOT_YET_RECRUITINGNCT07782125Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue DefectsRECRUITING

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Official Source

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