Cleared Traditional

JACK'S VENT TUBES

K923887 · O.R. Specialties, Inc. · Ear, Nose, Throat
Feb 1993
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K923887 is an FDA 510(k) clearance for the JACK'S VENT TUBES, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on February 19, 1993, 199 days after receiving the submission on August 4, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K923887 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1992
Decision Date February 19, 1993
Days to Decision 199 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

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