STERILE PLASTIC DRESSING— 510(k) K944588
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K944588 for STERILE PLASTIC DRESSING, Substantially Equivalent on 1994-11-07. Applicant: Smith & Nephew, Inc.. Device class: 1.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code KGX
- Device class
- Class 1
- Regulation
- 21 CFR 880.5240
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Quebec, CA
Recent devices under product code KGX
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- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
Adverse events under product code KGX
product code KGX- Injury
- 1,590
- Malfunction
- 1,357
- Other
- 3
- Total
- 2,950
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.