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)

DERMOTHERAP GUN

K-Number: K062339 · 2007-02-05

ApplicantDermoequipos S.R.L.
Decision Date2007-02-05
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMOTHERAP GUN is the device name listed in this FDA 510(k) record. The listed applicant is Dermoequipos S.R.L.. It received FDA 510(k) clearance on 2007-02-05 under 510(k) number K062339. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMOTHERAP GUN?

DERMOTHERAP GUN is a medical device that received FDA 510(k) clearance on 2007-02-05. The listed applicant is Dermoequipos S.R.L.. The 510(k) number is K062339.

When did DERMOTHERAP GUN receive FDA 510(k) clearance?

DERMOTHERAP GUN received FDA 510(k) clearance on 2007-02-05, under 510(k) number K062339.

Who is the listed applicant for DERMOTHERAP GUN?

The FDA 510(k) record lists Dermoequipos S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMOTHERAP GUN?

The FDA product code for DERMOTHERAP GUN is KZH.

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: KZH)

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.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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.

↑