SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV— 510(k) K141033
Substantially EquivalentArgentum Medical, LLC
FDA 510(k) clearance K141033 for SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV, Substantially Equivalent on 2014-09-12. Applicant: Argentum Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Argentum Medical, LLC
- Product code
- Code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geneva, IL, US
Recent devices under product code OMP
view allMore clearances from Argentum Medical, LLC
view all- K241225 — Silverlon® Wound Contact, Burn Contact Dressing
- K190343 — Silverlon Wound Contact, Burn Contact Dressings
- K180570 — Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
- K122817 — SILVERLON ISLAND WOUND DRESSING
- K053590 — SILVERLON CA (CALCIUM ALGINATE)
Adverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
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.