FDA 510(k)

LATERA Absorbable Nasal Implant System

Número K: K192661 · 2019-11-10

RequerenteEntellus Medical, Inc. (Aka Stryker Ent)

Data da decisão2019-11-10

Código do produtoNHB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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