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FDA 510(k)

OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016

K-Number: K041983 · 2004-11-17

ApplicantOpticon Medical
Decision Date2004-11-17
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 is the device name listed in this FDA 510(k) record. The listed applicant is Opticon Medical. It received FDA 510(k) clearance on 2004-11-17 under 510(k) number K041983. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016?

OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 is a medical device that received FDA 510(k) clearance on 2004-11-17. The listed applicant is Opticon Medical. The 510(k) number is K041983.

When did OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 receive FDA 510(k) clearance?

OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 received FDA 510(k) clearance on 2004-11-17, under 510(k) number K041983.

Who is the listed applicant for OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016?

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

What is the FDA product code for OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016?

The FDA product code for OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 is EZL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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