COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING— 510(k) K043296
Substantially EquivalentCovalontechnologies, Inc.
FDA 510(k) clearance K043296 for COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING, Substantially Equivalent on 2005-06-06. Applicant: Covalontechnologies, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Covalontechnologies, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, US
Recent devices under product code FRO
view allMore clearances from Covalontechnologies, Inc.
view all- K163556 — MediClear PreOp
- K150550 — SilverCoat Silicone Foley Catheter
- K121819 — SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
- K112549 — IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
- K050177 — COLACTIVE COLLAGEN WOUND DRESSING
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.