Medline Anti-Reflux Valve
FDA 510(k) K132314 · Medline Industries, Inc.
510(k) numberK132314
Submission
- Device name
- Medline Anti-Reflux Valve
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- July 25, 2013
- Decision date
- September 18, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FEG – Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression SetFEG · Traditional | Cook Ireland, Ltd. | 08/01/2017SE |
| K053410 | Gientriport with Universal Single Lumen AdaptorFEG · Traditional | Kendall | 01/06/2006SE |
| K040388 | Next Generation Salem SumpFEG · Traditional | Kendall | 05/17/2004SE |
| K971354 | Knott NG TubeFEG · Traditional | Michael M. Knott, M.D. | 11/19/1997SE |
| K960176 | Davol Nasogastric Sump Tube W/Prevent FilterFEG · Traditional | C.R. Bard, Inc. | 07/24/1996SE |
| K926073 | Ultravac-Ng(Tm) Nasogastric Sump Suction TubeFEG · Traditional | Surgimark, Inc. | 05/15/1995SE |
| K935781 | Argyle Salem Sump Tube Anti-Reflux Valve Insertion TrayFEG · Traditional | Sherwood Medical Co. | 01/27/1995SESK |
| K921104 | Lopez Valve with NG Sump TubeFEG · Traditional | Icu Medical, Inc. | 10/26/1992SE |
| K900035 | Wilson-Cook Colon Decompression SetFEG · Traditional | Wilson-Cook Medical, Inc. | 03/07/1990SE |
| K880850 | Keith Nasogastric Sump Tube W/Anti-Reflux ValveFEG · Traditional | Kmb Medical Products Co. | 05/26/1988SE |
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Questions and answers
When was Medline Anti-Reflux Valve cleared by the FDA?
Medline Anti-Reflux Valve (K132314) received a 510(k) decision of Substantially Equivalent on September 18, 2013, 55 days after the submission was received.
What is the product code of K132314?
The FDA product code is FEG – Tube, Double Lumen For Intestinal Decompression And/Or Intubation, a Class II (moderate risk) device regulated under 21 CFR 876.5980.