NEOZOLINE VENTILATION TUBES— 510(k) K061058
Substantially EquivalentAdept Medical, Ltd.
FDA 510(k) clearance K061058 for NEOZOLINE VENTILATION TUBES, Substantially Equivalent on 2006-07-12. Applicant: Adept Medical, Ltd.. Device class: 2.
Clearance details
- Applicant
- Adept Medical, Ltd.
- 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
- Auckland, NZ
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
Recalls naming K061058
K-number listed on FDA's recall record- Z-0963-2025 — Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
- Z-0965-2025 — Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
- Z-0966-2025 — Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
- Z-0967-2025 — Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
- Z-0968-2025 — Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
- Z-0969-2025 — Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
- Z-0970-2025 — Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061058.
Data sourced from openFDA. This site is unofficial and independent of the FDA.