Cleared Traditional

BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES

K062385 · Grace Medical, Inc. · Ear, Nose, Throat
Sep 2006
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K062385 is an FDA 510(k) clearance for the BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 27, 2006, 43 days after receiving the submission on August 15, 2006. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K062385 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2006
Decision Date September 27, 2006
Days to Decision 43 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETD — Tube, Tympanostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3880

Similar Devices — ETD Tube, Tympanostomy

All 114
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
K250256 · Aventamed Dac · Apr 2025
Solo+ Tympanostomy Tube Device (TTD)
K232702 · Aventamed Dac · May 2024
Biowy Tym Tube (TT)
K233658 · Biowy Corporation · Feb 2024
Tympanostomy Tubes
K232059 · Grace Medical, Inc. · Nov 2023
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022
Hummingbird Tympanostomy Tube System
K200952 · Preceptis Medical, Inc. · Jun 2020