FDA Product Code NHB: Polymer, Ear, Nose And Throat, Synthetic, Absorbable
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.
Leading manufacturers include Spirair, Inc. and Hemostasis, LLC.
FDA 510(k) Cleared Polymer, Ear, Nose And Throat, Synthetic, Absorbable Devices (Product Code NHB)
About Product Code NHB - Regulatory Context
510(k) Submission Activity
15 total 510(k) submissions under product code NHB since 2001, with 15 receiving FDA clearance (average review time: 146 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under NHB have taken an average of 219 days to reach a decision - up from 141 days historically. Manufacturers should account for longer review timelines in current project planning.
NHB devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →