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FDA 510(k)

Aquarius Stoma Measuring Device

K-Number: K152246 · 2016-06-21

ApplicantDegania Silicone , Ltd.
Decision Date2016-06-21
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Aquarius Stoma Measuring Device is a medical device manufactured by Degania Silicone , Ltd.. It received FDA 510(k) clearance on 2016-06-21 under approval number K152246. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aquarius Stoma Measuring Device?

Aquarius Stoma Measuring Device is a medical device that received FDA 510(k) clearance on 2016-06-21. It is manufactured by Degania Silicone , Ltd.. The 510(k) number is K152246.

When was Aquarius Stoma Measuring Device approved by the FDA?

Aquarius Stoma Measuring Device received FDA 510(k) clearance on 2016-06-21, under approval number K152246.

What company makes Aquarius Stoma Measuring Device?

Aquarius Stoma Measuring Device is manufactured by Degania Silicone , Ltd..

What is the FDA product code for Aquarius Stoma Measuring Device?

The FDA product code for Aquarius Stoma Measuring Device is KNT.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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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.

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