Set, Oral Administration
The Oral Administration Set is a medical device used to deliver fluids or medications orally or enterally to patients who cannot take nutrition or medications by normal means, typically employed in gastroenterological or urological care settings. The device is FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification to establish substantial equivalence. It carries product code LEY and is regulated under 21 CFR 876.5980 within the Gastroenterology and Urology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LEY
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- HO
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K760251 | SET, ORAL ADMINISTRATION | Sep 15, 1976 | Substantially Equivalent | Cis Radiopharmaceuticals, Inc. |