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FDA 510(k)

LATERA Absorbable Nasal Implant System

K-Number: K192661 · 2019-11-10

ApplicantEntellus Medical, Inc. (Aka Stryker Ent)
Decision Date2019-11-10
Product CodeNHB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Entellus Medical, Inc. (Aka Stryker Ent). The 510(k) number is K192661.

When was LATERA Absorbable Nasal Implant System approved by the FDA?

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

What company makes LATERA Absorbable Nasal Implant System?

LATERA Absorbable Nasal Implant System is manufactured by Entellus Medical, Inc. (Aka Stryker Ent).

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Related Devices (Code: NHB)

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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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