Solo+ Tympanostomy Tube Device (TTD) (Handpiece Catalogue #: 12115-100-000, Cartridge Catalogue #: 12115-200-000)

by Aventamed Dac

510(k) K250256Ref 12115-200-000Model Solo+ TTD

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250256↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK250256	Date28 Apr 2025Cleared	StatusActive
United States	GUDID listing GUDID	Number05391528890101 UDI-DI	Date19 Jul 2024Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDD EUDAMED	NumberB-05391528890101 Basic UDI-DI 05391528890101UDI-DI	Date9 Nov 2021Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Full name: 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))

Trade Name: Solo+ TTD EUDAMED
Solo+ TTD Cartridge GUDID
Generic Name: Tympanostomy tube
Model / Ref / Catalog: 12115-200-000, Solo+ TTD

Primary DI / UDI-DI: 05391528890101
Basic UDI-DI: B-05391528890101
510(k) Number: K250256 510(k)
K232702 GUDID
FDA Product Code: ETD
EMDN Code: Q03040101 Ear drainage and ventilation catheters and cannulas
GMDN Term: Tympanostomy tube

Device Class: Class IIb EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 874.3880
EU market of registration: Italy
Advisory Committee: Ear, Nose, Throat
FDA Decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Conditional

Size: Lumen/Inner Diameter — 1.14 Millimeter

Truth per registry

3 sources · 2 fields differ

Field	EUDAMED	510(k)	GUDID
510(k) Number	EUDAMED —	510(k) K250256	GUDID K232702
Device Class	EUDAMED Class IIb	510(k) Class II	GUDID Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Solo+ Tympanostomy Tube Device (TTD) is a medical device designed for the insertion of tympanostomy tubes into the middle ear, typically to relieve fluid buildup or pressure caused by conditions such as otitis media. Classified as a Class II device, it is intended for use in otolaryngological procedures to maintain tympanic membrane ventilation and drainage.

This system consists of a reusable handpiece (Catalogue #: 12115-100-000) and single-use cartridges (Catalogue #: 12115-200-000) for tube insertion. Supplied sterile, it is regulated under the FDA 510(k) pathway with Substantial Equivalence determination and EU Medical Device Directive (MDD) compliance. The device is intended for use in clinical settings by trained healthcare professionals and is not MRI-compatible.

Other devices from Aventamed Dac

Solo+ Tympanostomy Tube Device (TTD)

Class II
Solo+ TTD

Class IIb

Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (15)

Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No