FDA 510(k)

ALEXIS LAPAROSCOPIC SYSTEM

K-Number: K093296 · 2009-11-05

ApplicantApplied Medical Resources Corp.

Decision Date2009-11-05

Product CodeKGW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ALEXIS LAPAROSCOPIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2009-11-05 under 510(k) number K093296. 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 LAPAROSCOPIC SYSTEM?

ALEXIS LAPAROSCOPIC SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-05. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K093296.

When did ALEXIS LAPAROSCOPIC SYSTEM receive FDA 510(k) clearance?

ALEXIS LAPAROSCOPIC SYSTEM received FDA 510(k) clearance on 2009-11-05, under 510(k) number K093296.

Who is the listed applicant for ALEXIS LAPAROSCOPIC SYSTEM?

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

What is the FDA product code for ALEXIS LAPAROSCOPIC SYSTEM?

The FDA product code for ALEXIS LAPAROSCOPIC SYSTEM is KGW.

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Related Devices (Code: KGW)

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 Corporation K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)Applied Medical Resources Corporation K113268ALEXIS O WOUND PROTECTOR/RETRACTORApplied Medical Resources Corp.K100120ALEXIS ORTHOPAEDIC WOUND RETRACTORApplied Medical Resources Corp.K062907ALEXIS WOUND RETRACTORApplied Medical Resources 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.