Cleared Traditional

EXMOOR MYRINGOTOMY KIT

K980828 · Exmoor Plastics , Ltd. · Ear, Nose, Throat
Oct 1998
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K980828 is an FDA 510(k) clearance for the EXMOOR MYRINGOTOMY KIT, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on October 22, 1998, 233 days after receiving the submission on March 3, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K980828 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1998
Decision Date October 22, 1998
Days to Decision 233 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