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)

EUTROCHAR

K-Number: K050957 · 2005-05-18

ApplicantSpecial Devices, Inc.
Decision Date2005-05-18
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EUTROCHAR is the device name listed in this FDA 510(k) record. The listed applicant is Special Devices, Inc.. It received FDA 510(k) clearance on 2005-05-18 under 510(k) number K050957. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUTROCHAR?

EUTROCHAR is a medical device that received FDA 510(k) clearance on 2005-05-18. The listed applicant is Special Devices, Inc.. The 510(k) number is K050957.

When did EUTROCHAR receive FDA 510(k) clearance?

EUTROCHAR received FDA 510(k) clearance on 2005-05-18, under 510(k) number K050957.

Who is the listed applicant for EUTROCHAR?

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

What is the FDA product code for EUTROCHAR?

The FDA product code for EUTROCHAR is MDM.

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 Special Devices, 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.

K982354SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M

Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, Inc.K010184CHESS HAND SURGERY SYSTEMCanica Design, 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.

↑