OPSITE WOUND DRESSING— 510(k) K852211
Substantially Equivalent for Some IndicationsSmith & Nephew, Inc.
FDA 510(k) clearance K852211 for OPSITE WOUND DRESSING, Substantially Equivalent for Some Indications on 1985-07-23. Applicant: Smith & Nephew, Inc.. Device class: 1.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code NAD
- Device class
- Class 1
- Regulation
- 21 CFR 878.4020
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Columbia, SC, US
Recent devices under product code NAD
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- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
Adverse events under product code NAD
product code NAD- Injury
- 431
- Malfunction
- 11,935
- Other
- 1
- Total
- 12,367
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.