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)

TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC

K-Number: K111692 · 2011-11-08

ApplicantSomatex Medical Technologies GmbH
Decision Date2011-11-08
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC is the device name listed in this FDA 510(k) record. The listed applicant is Somatex Medical Technologies GmbH. It received FDA 510(k) clearance on 2011-11-08 under 510(k) number K111692. 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 TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC?

TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC is a medical device that received FDA 510(k) clearance on 2011-11-08. The listed applicant is Somatex Medical Technologies GmbH. The 510(k) number is K111692.

When did TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC receive FDA 510(k) clearance?

TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC received FDA 510(k) clearance on 2011-11-08, under 510(k) number K111692.

Who is the listed applicant for TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC?

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

What is the FDA product code for TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC?

The FDA product code for TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC 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 Somatex Medical Technologies GmbH 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.

K201863Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-ShapeK182082Tumark for Eviva, Tumark for BreveraK180443Tumark VisionK102771BIOPSY HANDY, MRI BIOPSY HANDYK093064TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560K073095TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560

View all 7 devices →

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.

↑