Tube, Levine
A Levine tube is a type of nasogastric tube inserted through the nose into the stomach, used for gastric decompression, enteral feeding, or medication administration in clinical settings. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FRQ, regulated under 21 CFR 876.5980, within the Gastroenterology, Urology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FRQ
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914887 | ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT | May 08, 1992 | Substantially Equivalent | Mallinckrodt Medical |
| K914530 | ICAN GT DRAINAGE BAG | Dec 18, 1991 | Substantially Equivalent | Icn Pharmaceuticals, Inc. |
| K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | Sep 26, 1980 | Substantially Equivalent | Pollak (Intl.), Ltd. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.