FDA 510(k)

HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

K-Nummer: K253761 · 2026-01-23

AntragstellerDevicor Medical Products, Inc.

Entscheidungsdatum2026-01-23

ProduktcodeNEU

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) 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 2026-01-23 under 510(k) number K253761. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)?

HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K253761.

When did HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) receive FDA 510(k) clearance?

HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) received FDA 510(k) clearance on 2026-01-23, under 510(k) number K253761.

Who is the listed applicant for HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)?

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™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)?

The FDA product code for HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) is NEU.

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Weitere Einträge mit Devicor Medical Products, Inc. als Antragsteller

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 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 K212158HydroMARK Breast Biopsy Site Marker

Alle 14 Geräte anzeigen →

Verwandte Geräte (Code: NEU)

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.K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc.

Offizielle Quelle

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