Nutrisafe Extension Tube
FDA 510(k) K991918 · Vygon Corp.
510(k) numberK991918
Submission
- Device name
- Nutrisafe Extension Tube
- Applicant
- Vygon Corp.
West Cadwell, NJ, US - Received
- June 7, 1999
- Decision date
- October 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
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| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
More from Degania Silicone , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K241587 | pilot TLSLJS · Traditional | 02/26/2025SE |
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| K141026 | LeaderflexFOZ · Traditional | 07/30/2014SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | 10/13/2011SE |
| K073493 | Hepatostat SetGAM · Traditional | 05/06/2008SE |
| K070705 | Modification to: Latex-Free Bionector, Model# 896.019, 896.039FOZ · Traditional | 11/30/2007SE |
| K061796 | Hepatostat Set, Model 760XGAM · Traditional | 11/02/2006SE |
| K061250 | Multicath ExpertFOZ · Traditional | 09/29/2006SE |
| K062425 | Lifecath S Picc and Midline CatheterLJS · Special | 09/15/2006SE |
Questions and answers
When was Nutrisafe Extension Tube cleared by the FDA?
Nutrisafe Extension Tube (K991918) received a 510(k) decision of Substantially Equivalent on October 29, 1999, 144 days after the submission was received.
What is the product code of K991918?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.