Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)— 510(k) K180570
Substantially EquivalentArgentum Medical, LLC
FDA 510(k) clearance K180570 for Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing), Substantially Equivalent on 2019-01-14. Applicant: Argentum Medical, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Argentum Medical, LLC
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geneva, IL, US
Recent devices under product code FRO
view allMore clearances from Argentum Medical, LLC
view all- K241225 — Silverlon® Wound Contact, Burn Contact Dressing
- K190343 — Silverlon Wound Contact, Burn Contact Dressings
- K141033 — SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV
- K122817 — SILVERLON ISLAND WOUND DRESSING
- K053590 — SILVERLON CA (CALCIUM ALGINATE)
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.