Field Shield Wound Dressing— 510(k) K212521
Substantially EquivalentKericure, Inc.
FDA 510(k) clearance K212521 for Field Shield Wound Dressing, Substantially Equivalent on 2024-07-18. Applicant: Kericure, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Kericure, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wesley Chapel, FL, US
Recent devices under product code FRO
view allMore clearances from Kericure, Inc.
view allAdverse 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.