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)

ALEXIS WOUND RETRACTOR

K-Number: K062907 · 2007-01-09

ApplicantApplied Medical Resources
Decision Date2007-01-09
Product CodeKGW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALEXIS WOUND RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 2007-01-09 under 510(k) number K062907. The device is classified under product code KGW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALEXIS WOUND RETRACTOR?

ALEXIS WOUND RETRACTOR is a medical device that received FDA 510(k) clearance on 2007-01-09. The listed applicant is Applied Medical Resources. The 510(k) number is K062907.

When did ALEXIS WOUND RETRACTOR receive FDA 510(k) clearance?

ALEXIS WOUND RETRACTOR received FDA 510(k) clearance on 2007-01-09, under 510(k) number K062907.

Who is the listed applicant for ALEXIS WOUND RETRACTOR?

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

What is the FDA product code for ALEXIS WOUND RETRACTOR?

The FDA product code for ALEXIS WOUND RETRACTOR is KGW.

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 Applied Medical Resources 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.

K200021Applied Medical AnoscopeK162676Voyant Open Fusion DeviceK153017Voyant Fine FusionK153288Voyant Open Fusion DeviceK151480Epix Electrosurgical Probe with Smoke EvacuationK100959SPECIMEN RETRIEVAL SYSTEM

View all 53 devices →

Related Devices (Code: KGW)

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.

K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)Applied Medical Resources CorporationK253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)Applied Medical Resources CorporationK113268ALEXIS O WOUND PROTECTOR/RETRACTORApplied Medical Resources Corp.K100120ALEXIS ORTHOPAEDIC WOUND RETRACTORApplied Medical Resources Corp.K093296ALEXIS LAPAROSCOPIC SYSTEMApplied Medical Resources Corp.K041711ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304Applied Medical Resources Corp.

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.

↑