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FDA 510(k)

BIOPSY SITE TISSUE MARKER DEVICE

K-Number: K023450 · 2002-12-19

ApplicantPromex, Inc.
Decision Date2002-12-19
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOPSY SITE TISSUE MARKER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 2002-12-19 under 510(k) number K023450. 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 BIOPSY SITE TISSUE MARKER DEVICE?

BIOPSY SITE TISSUE MARKER DEVICE is a medical device that received FDA 510(k) clearance on 2002-12-19. The listed applicant is Promex, Inc.. The 510(k) number is K023450.

When did BIOPSY SITE TISSUE MARKER DEVICE receive FDA 510(k) clearance?

BIOPSY SITE TISSUE MARKER DEVICE received FDA 510(k) clearance on 2002-12-19, under 510(k) number K023450.

Who is the listed applicant for BIOPSY SITE TISSUE MARKER DEVICE?

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

What is the FDA product code for BIOPSY SITE TISSUE MARKER DEVICE?

The FDA product code for BIOPSY SITE TISSUE MARKER DEVICE is NEU.

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Other records listing Promex, Inc. as applicant

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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

View on FDA Database →

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

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