FDA 510(k)

LATERA Absorbable Nasal Implant System

K-Nummer: K192661 · 2019-11-10

AntragstellerEntellus Medical, Inc. (Aka Stryker Ent)

Entscheidungsdatum2019-11-10

ProduktcodeNHB

BeratungsausschussEN

EntscheidungSubstantially Equivalent

Produktübersicht

LATERA Absorbable Nasal Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Entellus Medical, Inc. (Aka Stryker Ent). It received FDA 510(k) clearance on 2019-11-10 under 510(k) number K192661. The device is classified under product code NHB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the LATERA Absorbable Nasal Implant System?

LATERA Absorbable Nasal Implant System is a medical device that received FDA 510(k) clearance on 2019-11-10. The listed applicant is Entellus Medical, Inc. (Aka Stryker Ent). The 510(k) number is K192661.

When did LATERA Absorbable Nasal Implant System receive FDA 510(k) clearance?

LATERA Absorbable Nasal Implant System received FDA 510(k) clearance on 2019-11-10, under 510(k) number K192661.

Who is the listed applicant for LATERA Absorbable Nasal Implant System?

The FDA 510(k) record lists Entellus Medical, Inc. (Aka Stryker Ent) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATERA Absorbable Nasal Implant System?

The FDA product code for LATERA Absorbable Nasal Implant System is NHB.

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Verwandte Geräte (Code: NHB)

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