FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
K Number: K253580
·
Decision Apr 26, 2026
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
34
Applicant Total
1
Review Days
160
Basic Information
- Device Name
- Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
- K Number
- K253580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tedan Surgical Innovations
- Date Received
- November 17, 2025
- Decision Date
- April 26, 2026
- Product Code
- PDQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| PDQ | Neurosurgical Nerve Locator | FDA class 2 | Ear, Nose, Throat |
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