Ventilation (Tympanostomy) Tubes— 510(k) K151067
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K151067 for Ventilation (Tympanostomy) Tubes, Substantially Equivalent on 2015-07-22. Applicant: Medtronic Xomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Code ETD
- Device class
- Class 2
- Regulation
- 21 CFR 874.3880
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code ETD
view all- K252436 — Tula Tympanostomy Tube Delivery Device
- K250256 — 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))
- K232702 — Solo+ Tympanostomy Tube Device (TTD)
- K233658 — Biowy Tym Tube (TT)
- K232059 — Tympanostomy Tubes
More clearances from Medtronic Xomed, Inc.
view all- K262235 — ApexCut Blade with Automated EM Tracking (6 models)
- K251672 — NIM Essence EMG Endotracheal Tube (5 models)
- K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
- K231580 — NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
- K213246 — NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
Data sourced from openFDA. This site is unofficial and independent of the FDA.