FDA 510(k)

ReNew Disposable Scissor Tips

N.º K: K213127 · 2022-03-02

Fecha de decisión2022-03-02

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ReNew Disposable Scissor Tips is the device name listed in this FDA 510(k) record. The listed applicant is Microline Surgical, Inc.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213127. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ReNew Disposable Scissor Tips?

ReNew Disposable Scissor Tips is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K213127.

When did ReNew Disposable Scissor Tips receive FDA 510(k) clearance?

ReNew Disposable Scissor Tips received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213127.

Who is the listed applicant for ReNew Disposable Scissor Tips?

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

What is the FDA product code for ReNew Disposable Scissor Tips?

The FDA product code for ReNew Disposable Scissor Tips is GEI.

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Otros registros que enlistan a Microline Surgical, Inc. como solicitante

K234147ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)K201884ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm K160706ReNew V Handpiece Laparoscopic Instruments K152745ReNew Sterilization Trays(Catalog #3708 and #3709)K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

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Fuente oficial

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