Protector, Wound, Plastic
The plastic wound protector is a device placed at a surgical incision to retract and protect the wound edges from contamination and mechanical trauma during abdominal or thoracic surgery, reducing the risk of wound infection and facilitating access. It is classified as FDA Class 1, indicating minimal risk, and requires 510(k) premarket clearance despite its Class 1 designation due to the submission type. The product code is EYF, regulated under 21 CFR 878.4014 in the General, Plastic Surgery specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
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Basic Information
- Product Code
- EYF
- Device Class
- FDA class 1
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K922785 | IRRIVAGE | Oct 16, 1992 | Substantially Equivalent | Autovage |
| K911407 | HARDING STERNAL SHIELD | Jul 05, 1991 | Substantially Equivalent | Harding Medical Devices |
| K910104 | ANTI-FOG DISPOSABLE IV INDUCTION COVER | Apr 12, 1991 | Substantially Equivalent | Central Plastic, Inc. |
| K904389 | SI-PRO | Dec 17, 1990 | Substantially Equivalent | David F. Trungale |
| K832908 | COMFEEL PROTECTIVE RINGS | Dec 12, 1983 | Substantially Equivalent | Coloplast A/S |