TubaVent Balloon Dilatation System— 510(k) K223542
Substantially EquivalentSpiggle & Theis Medizintechnik GmbH
FDA 510(k) clearance K223542 for TubaVent Balloon Dilatation System, Substantially Equivalent on 2023-08-03. Applicant: Spiggle & Theis Medizintechnik GmbH. Device class: 2.
Clearance details
- Applicant
- Spiggle & Theis Medizintechnik GmbH
- Product code
- Code PNZ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4180
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overath, DE
Recent devices under product code PNZ
view all- K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System
- K230742 — ACCLARENT AERA Eustachian Tube Dilation System
- K230065 — VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
- K220027 — Audion ET dilation system
- K210841 — NuVent Eustachian Tube Dilation Balloon
Data sourced from openFDA. This site is unofficial and independent of the FDA.