FDA 510(k)

HydroMARK Breast Biopsy Site Markers

N.º K: K170803 · 2017-06-15

SolicitanteDevicor Medical Products, Inc.

Fecha de decisión2017-06-15

Código de productoNEU

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

HydroMARK Breast Biopsy Site Markers is the device name listed in this FDA 510(k) record. The listed applicant is Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K170803. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HydroMARK Breast Biopsy Site Markers?

HydroMARK Breast Biopsy Site Markers is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K170803.

When did HydroMARK Breast Biopsy Site Markers receive FDA 510(k) clearance?

HydroMARK Breast Biopsy Site Markers received FDA 510(k) clearance on 2017-06-15, under 510(k) number K170803.

Who is the listed applicant for HydroMARK Breast Biopsy Site Markers?

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

What is the FDA product code for HydroMARK Breast Biopsy Site Markers?

The FDA product code for HydroMARK Breast Biopsy Site Markers is NEU.

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Otros registros que enlistan a Devicor Medical Products, Inc. como solicitante

K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)K243095Mammotome AutoCore™ Single Insertion Core Biopsy System K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))K221961HydroMARK Plus Breast Biopsy Site Marker

Ver todos los 14 dispositivos →

Dispositivos relacionados (Código: NEU)

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker Endoscopy K252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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