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)

BEACON TISSUE MARKER

K-Number: K130763 · 2013-05-08

ApplicantScion Medical Technologies, LLC
Decision Date2013-05-08
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BEACON TISSUE MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Scion Medical Technologies, LLC. It received FDA 510(k) clearance on 2013-05-08 under 510(k) number K130763. 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 BEACON TISSUE MARKER?

BEACON TISSUE MARKER is a medical device that received FDA 510(k) clearance on 2013-05-08. The listed applicant is Scion Medical Technologies, LLC. The 510(k) number is K130763.

When did BEACON TISSUE MARKER receive FDA 510(k) clearance?

BEACON TISSUE MARKER received FDA 510(k) clearance on 2013-05-08, under 510(k) number K130763.

Who is the listed applicant for BEACON TISSUE MARKER?

The FDA 510(k) record lists Scion Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEACON TISSUE MARKER?

The FDA product code for BEACON TISSUE MARKER is NEU.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Scion Medical Technologies, 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.

K170905Star Tissue MarkerK161234CASSI II Rotational Core Biopsy SystemK123606CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE

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.

↑