Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Trilogy Tissue Marker

K-Number: K240429 · 2024-11-07

ApplicantInrad, Inc.
Decision Date2024-11-07
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Trilogy Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Inrad, Inc.. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K240429. 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 Trilogy Tissue Marker?

Trilogy Tissue Marker is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Inrad, Inc.. The 510(k) number is K240429.

When did Trilogy Tissue Marker receive FDA 510(k) clearance?

Trilogy Tissue Marker received FDA 510(k) clearance on 2024-11-07, under 510(k) number K240429.

Who is the listed applicant for Trilogy Tissue Marker?

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

What is the FDA product code for Trilogy Tissue Marker?

The FDA product code for Trilogy Tissue Marker is NEU.

Other records listing Inrad, Inc. 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.

K243886ExpressCore Biopsy DeviceK183503EasyMark Tissue Marker

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.

↑