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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 the device name listed in this FDA 510(k) record. The listed applicant is Degania Silicone , Ltd.. It received FDA 510(k) clearance on 2016-06-21 under 510(k) 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. The listed applicant is Degania Silicone , Ltd.. The 510(k) number is K152246.

When did Aquarius Stoma Measuring Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Aquarius Stoma Measuring Device?

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

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

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

Other records listing Degania Silicone , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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