FDA 510(k)

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

N.º K: K152743 · 2016-02-08

Fecha de decisión2016-02-08

Código de productoKCT

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) 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 2016-02-08 under 510(k) number K152743. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)?

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) is a medical device that received FDA 510(k) clearance on 2016-02-08. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K152743.

When did M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) receive FDA 510(k) clearance?

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) received FDA 510(k) clearance on 2016-02-08, under 510(k) number K152743.

Who is the listed applicant for M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)?

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 M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)?

The FDA product code for M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) is KCT.

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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)K213127ReNew Disposable Scissor Tips 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)

Dispositivos relacionados (Código: KCT)

K253988LiteSet TraysNobel Biocare AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

Fuente oficial

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