FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tula Tympanostomy Tube Delivery Device
K Number: K252436
·
Decision Apr 23, 2026
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
1
Review Days
265
Basic Information
- Device Name
- Tula Tympanostomy Tube Delivery Device
- K Number
- K252436
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tusker Medical, Inc.
- Date Received
- August 1, 2025
- Decision Date
- April 23, 2026
- Product Code
- ETD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ETD | Tube, Tympanostomy | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETD), ordered by most recent decision date.
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))
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