FDA 510(k)

OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES

K-Number: K945262 · 1995-05-26

Decision Date1995-05-26

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Optus, Inc.. It received FDA 510(k) clearance on 1995-05-26 under 510(k) number K945262. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES?

OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES is a medical device that received FDA 510(k) clearance on 1995-05-26. The listed applicant is Optus, Inc.. The 510(k) number is K945262.

When did OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES receive FDA 510(k) clearance?

OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES received FDA 510(k) clearance on 1995-05-26, under 510(k) number K945262.

Who is the listed applicant for OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES?

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

What is the FDA product code for OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES?

The FDA product code for OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES is FAJ.

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Other records listing Optus, Inc. as applicant

K945264OPTUS OTOSCOPES K953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES K945268OPTUS BRONCHOSCOPES K945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES K945267OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES K945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES

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Related Devices (Code: FAJ)

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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.