Knott NG Tube
FDA 510(k) K971354 · Michael M. Knott, M.D.
510(k) numberK971354
Submission
- Device name
- Knott NG Tube
- Applicant
- Michael M. Knott, M.D.
Tahoe City, CA, US - Received
- April 11, 1997
- Decision date
- November 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code FEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression SetFEG · Traditional | Cook Ireland, Ltd. | 08/01/2017SE |
| K132314 | Medline Anti-Reflux ValveFEG · Traditional | Medline Industries, Inc. | 09/18/2013SE |
| K053410 | Gientriport with Universal Single Lumen AdaptorFEG · Traditional | Kendall | 01/06/2006SE |
| K040388 | Next Generation Salem SumpFEG · Traditional | Kendall | 05/17/2004SE |
| 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 |
More from Kmb Medical Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K981966 | Nosebleed NoseclipEMX · Traditional | 08/14/1998SE |
Questions and answers
When was Knott NG Tube cleared by the FDA?
Knott NG Tube (K971354) received a 510(k) decision of Substantially Equivalent on November 19, 1997, 222 days after the submission was received.
What is the product code of K971354?
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.