Decision Date2016-11-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Disposal Lens Cleaning Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K153773. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposal Lens Cleaning Sheath?
Disposal Lens Cleaning Sheath is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K153773.
When did Disposal Lens Cleaning Sheath receive FDA 510(k) clearance?
Disposal Lens Cleaning Sheath received FDA 510(k) clearance on 2016-11-22, under 510(k) number K153773.
Who is the listed applicant for Disposal Lens Cleaning Sheath?
The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposal Lens Cleaning Sheath?
The FDA product code for Disposal Lens Cleaning Sheath is GCJ.
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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.