FDA 510(k)

HydroMARK Breast Biopsy Site Marker

Numéro K : K161021 · 2016-05-05

Date de décision2016-05-05

Code produitNEU

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

HydroMARK Breast Biopsy Site Marker 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 2016-05-05 under 510(k) number K161021. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the HydroMARK Breast Biopsy Site Marker?

HydroMARK Breast Biopsy Site Marker is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K161021.

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

HydroMARK Breast Biopsy Site Marker received FDA 510(k) clearance on 2016-05-05, under 510(k) number K161021.

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

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 Marker?

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

Essais cliniques associés

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Autres dossiers indiquant Devicor Medical Products, Inc. en tant que demandeur

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

Voir tous les 14 dispositifs →

Dispositifs connexes (Code : 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.

Source officielle

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