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510(k) K192661

LATERA Absorbable Nasal Implant System by Entellus Medical, Inc. (Aka Stryker Ent) — Product Code NHB

K192661 is an FDA 510(k) premarket notification submitted by Entellus Medical, Inc. (Aka Stryker Ent) for the device "LATERA Absorbable Nasal Implant System". The FDA issued a decision of Substantially Equivalent on November 10, 2019. The device falls under product code NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable), a Class II device regulated under 21 CFR 874.3620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2019
Date Received
September 25, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.

Other clearances for product code NHB

  • K251790 — SeptAlign (January 16, 2026)
  • K233569 — SeptAlign (March 22, 2024)
  • K223167 — Spirair Nasal Septal Strap (August 17, 2023)
  • K210411 — PosiSep EAR Fragmentable Ear Dressing (May 5, 2022)
  • K183015 — PuraSinus (April 12, 2019)
  • K161191 — Latera Absorbable Nasal Implant (June 23, 2016)
  • K152958 — INEX Absorbable Nasal Implant (December 4, 2015)
  • K132920 — SPIROX INEX DEVICE (June 10, 2014)
  • K122434 — MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL (October 31, 2012)
  • K092590 — PDS PLATES (February 17, 2010)

FDA data resources