Smith & Nephew Off-Centered Porp

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K002464 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Fluoroplastic Ventilation Tubes

  Class II

  FDA 510(k) K992222 Active Cleared 26 Aug 1999

• Gyrus ENT Nerve Stimulator

  Class II

  FDA 510(k) K021595 Active Cleared 24 Oct 2002

• Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid System

  Class II

  FDA 510(k) K040996 Active Cleared 20 Aug 2004

• Modular Porp And Torp Model Tbd

  Class II

  FDA 510(k) K002378 Active Cleared 29 Aug 2000

• ENT Irrigating Pump (70327700)

  Class II

  FDA 510(k) K973286 Active Cleared 29 Sep 1997

• Smith & Nephew Pistons

  Class II

  FDA 510(k) K003214 Active Cleared 31 Oct 2000

See all devices from Gyrus Ent LLC →