SILICONE TYMPANOSTOMY TUBES— 510(k) K932166
Substantially EquivalentSmith & Nephew Richards, Inc.
FDA 510(k) clearance K932166 for SILICONE TYMPANOSTOMY TUBES, Substantially Equivalent on 1993-07-26. Applicant: Smith & Nephew Richards, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew Richards, 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
- Bartlett, TN, 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 Smith & Nephew Richards, Inc.
view allRecalls naming K932166
K-number listed on FDA's recall record- Z-0707-2025 — Duravent Silicone Ventilation Tube. Model Number: 240075.
- Z-1004-2024 — Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932166.
Data sourced from openFDA. This site is unofficial and independent of the FDA.