FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ACTICOAT FLEX 7 DRESSING
K Number: K083113
·
Decision Jul 22, 2009
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
529
Review Days
274
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
- ACTICOAT FLEX 7 DRESSING
- K Number
- K083113
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- October 21, 2008
- Decision Date
- July 22, 2009
- 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, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Apr 6, 2026 | Substantially Equivalent |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Oct 29, 2025 | Substantially Equivalent |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Oct 3, 2025 | Substantially Equivalent |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | Jun 25, 2025 | Substantially Equivalent |
| K243608 | TRIGEN Stable Lock Nut & Washer | Jun 12, 2025 | Substantially Equivalent |
| K250677 | LEGION Total Knee System | Apr 2, 2025 | Substantially Equivalent |
| K250571 | CATALYSTEM Femoral Stems | Mar 28, 2025 | Substantially Equivalent |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Dec 9, 2024 | Substantially Equivalent |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Nov 20, 2024 | Substantially Equivalent |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Oct 30, 2024 | Substantially Equivalent |