Next Generation Salem Sump
FDA 510(k) K040388 · Kendall
510(k) numberK040388
Submission
- Device name
- Next Generation Salem Sump
- Applicant
- Kendall
Mansfield, MA, US - Received
- February 17, 2004
- Decision date
- May 17, 2004
- 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 |
| 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 |
More from Kmb Medical Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K092797 | Acute and Chronic Catheter Repair KitNFK · Traditional | 11/19/2009SESK |
| K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…MSD · Special | 11/03/2006SESK |
| K061936 | Kendall Argyle Neonatal/Pediatric Picc, Model 43311LJS · Special | 08/09/2006SE |
| K060972 | Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)MSD · Traditional | 08/04/2006SE |
| K053410 | Gientriport with Universal Single Lumen AdaptorFEG · Traditional | 01/06/2006SE |
| K051584 | 14.5 FR Chronic Hemodialysis Catheter with Insertion Stylets AccessoryMSD · Special | 10/06/2005SE |
| K043272 | Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical TipMSD · Special | 12/22/2004SE |
| K042461 | Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304LJS · Abbreviated | 12/10/2004SE |
| K042572 | Kendall CO2NFIRM Now CO2 DetectorKNT · Traditional | 11/05/2004SE |
| K041914 | Pallindrome 14.5FR Chronic Hemodialysis CatheterMSD · Traditional | 09/27/2004SE |
Questions and answers
When was Next Generation Salem Sump cleared by the FDA?
Next Generation Salem Sump (K040388) received a 510(k) decision of Substantially Equivalent on May 17, 2004, 90 days after the submission was received.
What is the product code of K040388?
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.