FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
IODOFLEX
K Number: K190756
·
Decision Dec 20, 2019
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
8
Review Days
270
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IODOFLEX
- K Number
- K190756
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew Medical, Ltd.
- Date Received
- March 25, 2019
- Decision Date
- December 20, 2019
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRO), ordered by most recent decision date.
Bonvadis®
FDA 510(k)
FDA Unclassified
·Unknown
StatSeal Disc
FDA 510(k)
FDA Unclassified
·Unknown
IWD-Gel
FDA 510(k)
FDA Unclassified
·Unknown
MiraChlor Antimicrobial Wound Solution
FDA 510(k)
FDA Unclassified
·Unknown
Promogran Prisma Collagen Matrix with ORC and Silver
FDA 510(k)
FDA Unclassified
·Unknown
LUOFUCON® Antimicrobial Wound Gel
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Smith & Nephew Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260646 | RENASYS EDGE (66803126) | May 27, 2026 | Substantially Equivalent |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Sep 11, 2025 | Substantially Equivalent |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | Feb 18, 2025 | Substantially Equivalent |
| K231939 | Renasys Edge | May 24, 2024 | Substantially Equivalent |
| K190730 | IODOSORB | Dec 20, 2019 | Substantially Equivalent |
| K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply | Aug 4, 2016 | Substantially Equivalent |
| K151436 | PICO Single Use Negative Pressure Wound Therapy System | Jan 28, 2016 | Substantially Equivalent |