FDA 510(k)

HYPNOSPAD

K-Number: K152660 · 2016-11-09

Decision Date2016-11-09

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HYPNOSPAD is the device name listed in this FDA 510(k) record. The listed applicant is Somnics, Inc.. It received FDA 510(k) clearance on 2016-11-09 under 510(k) number K152660. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPNOSPAD?

HYPNOSPAD is a medical device that received FDA 510(k) clearance on 2016-11-09. The listed applicant is Somnics, Inc.. The 510(k) number is K152660.

When did HYPNOSPAD receive FDA 510(k) clearance?

HYPNOSPAD received FDA 510(k) clearance on 2016-11-09, under 510(k) number K152660.

Who is the listed applicant for HYPNOSPAD?

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

What is the FDA product code for HYPNOSPAD?

The FDA product code for HYPNOSPAD is LRK.

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