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)

ENDOTOOL DRUG DOSE CALCULATOR

K-Number: K053137 · 2006-06-14

ApplicantMD Scientific, LLC
Decision Date2006-06-14
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENDOTOOL DRUG DOSE CALCULATOR is the device name listed in this FDA 510(k) record. The listed applicant is MD Scientific, LLC. It received FDA 510(k) clearance on 2006-06-14 under 510(k) number K053137. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOTOOL DRUG DOSE CALCULATOR?

ENDOTOOL DRUG DOSE CALCULATOR is a medical device that received FDA 510(k) clearance on 2006-06-14. The listed applicant is MD Scientific, LLC. The 510(k) number is K053137.

When did ENDOTOOL DRUG DOSE CALCULATOR receive FDA 510(k) clearance?

ENDOTOOL DRUG DOSE CALCULATOR received FDA 510(k) clearance on 2006-06-14, under 510(k) number K053137.

Who is the listed applicant for ENDOTOOL DRUG DOSE CALCULATOR?

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

What is the FDA product code for ENDOTOOL DRUG DOSE CALCULATOR?

The FDA product code for ENDOTOOL DRUG DOSE CALCULATOR is NDC.

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

Related Devices (Code: NDC)

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.

K254102GlucommanderGlytec, LLCK260910EndoTool IV Cloud 1.0Glooko, Inc.K253512MiniMed Go AppMedtronic MinimedK253281UpDocUpdoc, Inc.K252104T1D1Comerge AGK241088EndoTool IV (3.1)Monarch Medical Technologies

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.

↑