Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
The pure latex sheet surgical drape with self-retaining finger cot is a sterile barrier device used to maintain a clean surgical field while providing a built-in protective finger cover, used in urological or general surgical procedures. It is classified as FDA Class 2, indicating moderate risk, and requires premarket clearance. The product code is EYX, regulated under 21 CFR 878.4370 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
- EYX
- Device Class
- FDA class 2
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K760175 | DRAPE, TRANSURETHRAL RESECTION (TUR) | Aug 30, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.