510(k) K233658
K233658 is an FDA 510(k) premarket notification submitted by Biowy Corporation for the device "Biowy Tym Tube (TT)". The FDA issued a decision of Substantially Equivalent on February 16, 2024. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Biowy Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2024
- Date Received
- November 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tympanostomy
- Device Class
- Class II
- Regulation Number
- 874.3880
- Review Panel
- EN
- Submission Type