Lopez Valve with NG Sump Tube
FDA 510(k) K921104 · Icu Medical, Inc.
510(k) numberK921104
Submission
- Device name
- Lopez Valve with NG Sump Tube
- Applicant
- Icu Medical, Inc.
Irvine, CA, US - Received
- March 9, 1992
- Decision date
- October 26, 1992
- 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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|---|---|---|---|
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| 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 |
| 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 Lopez Valve with NG Sump Tube cleared by the FDA?
Lopez Valve with NG Sump Tube (K921104) received a 510(k) decision of Substantially Equivalent on October 26, 1992, 231 days after the submission was received.
What is the product code of K921104?
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.