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FDA 510(k)

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

N.º K: K213125 · 2021-10-27

SolicitanteSynovis Life Technologies. Inc. (A Subsidiary of Baxter
Fecha de decisión2021-10-27
Código de productoFTM
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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