PolypVac® 3.3mm Microdebrider

Trade name

PolypVac®

Generic name

ENT shaver system handpiece

Model / Ref / Catalog

3.3mm Microdebrider, FG-000016

Primary DI / UDI-DI

00862519000304

FDA product code

ERL

GMDN term

ENT shaver system handpiece

Device class

Class II

Regulation number

874.4250

GUDID distribution status

In Commercial Distribution

Category: ENT shaver system handpiece

Other devices filed under FDA product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece).

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• PolypVac® 4.0mm Microdebrider

  Class II

  GUDID on market

• Laurimed Spinal Injection System

  Class II

  FDA 510(k) K080140 Active Cleared 9 May 2008

• 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider

  Class II

  FDA 510(k) K163247 Active Cleared 9 Mar 2017

• PolypVac Microdebrider (3.3mm and 4.0mm)

  Class II

  FDA 510(k) K161101 Active Cleared 22 Jun 2016

See all devices from Laurimed, LLC →