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FDA 510(k)

MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS

K-Number: K082278 · 2008-12-16

ApplicantEthicon Endo-Sugery, LLC
Decision Date2008-12-16
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Sugery, LLC. It received FDA 510(k) clearance on 2008-12-16 under 510(k) number K082278. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS?

MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Ethicon Endo-Sugery, LLC. The 510(k) number is K082278.

When did MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS receive FDA 510(k) clearance?

MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS received FDA 510(k) clearance on 2008-12-16, under 510(k) number K082278.

Who is the listed applicant for MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS?

The FDA 510(k) record lists Ethicon Endo-Sugery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS?

The FDA product code for MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS is NEU.

Related Clinical Trials

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Other records listing Ethicon Endo-Sugery, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112033ENSEAL G2 TISSUS SEALERSK101990ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11K110699LIGAMAX 5K091211EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORSK080972ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP

Related Devices (Code: NEU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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