INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING— 510(k) K872624
Substantially Equivalent for Some IndicationsSmith & Nephew, Inc.
FDA 510(k) clearance K872624 for INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING, Substantially Equivalent for Some Indications on 1987-07-29. Applicant: Smith & Nephew, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Massillon, OH, US
Recent devices under product code FRO
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- K254084 — AETOS Shoulder System - CONCELOC Glenoids
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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.