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LATERA Absorbable Nasal Implant System

by Entellus Medical, Inc. (Aka Stryker Ent) 510(k)

Active United States

510(k) K192661

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK192661 Date10 Nov 2019ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NHB
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent