FDA 510(k)
FDA class 2
Unknown
🇮🇱 Israel
iTind System
K Number: DEN190020
·
Decision Feb 25, 2020
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
2
Applicant Total
2
Review Days
329
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Basic Information
- Device Name
- iTind System
- K Number
- DEN190020
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.5510
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Medi-Tate , Ltd.
- Date Received
- April 2, 2019
- Decision Date
- February 25, 2020
- Product Code
- QKA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| QKA | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QKA), ordered by most recent decision date.
Urocross Expander System (Model Numbers ES2018 and ES3025)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
iTind System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Medi-Tate , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K210138 | iTind System | Jun 25, 2021 | Substantially Equivalent |