Vygon Enternal Nutrition Tubes
FDA 510(k) K820176 · Exco, Inc.
510(k) numberK820176
Submission
- Device name
- Vygon Enternal Nutrition Tubes
- Applicant
- Exco, Inc.
Mchenry, IL, US - Received
- January 22, 1982
- Decision date
- February 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | Boehringer Laboratories, LLC | 08/14/2026SE |
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
| K250389 | XNY Disposable Gastric Calibration TubeKNT · Traditional | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 04/10/2025SE |
| K243228 | Flexi-Seal AIR (with ENFit Connector)KNT · Traditional | Convatec | 03/28/2025SE |
| K242336 | hygh-tec Drainage IIKNT · Traditional | Amb Medtec | 01/17/2025SE |
| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
| K241169 | Entarik NI Feeding Tube SystemKNT · Traditional | Gravitas Medical, Inc. | 11/22/2024SE |
| K241185 | CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional | Avanos Medical, Inc. | 10/25/2024SE |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | Avanos Medical, Inc. | 06/06/2024SE |
| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
More from Degania Silicone , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K844203 | Enternal Feeding Tube SILICONE-EF401, 402 & 403KNT · Traditional | 01/02/1985SE |
| K844175 | Enternal Feeding Tube-Polyurethane EF504KNT · Traditional | 01/02/1985SE |
| K844174 | Flexible Stainless Steel Stylet for Enternal FeediKNT · Traditional | 12/07/1984SE |
| K832628 | Vygon Thoracic Drainage-Various #'SKDD · Traditional | 01/30/1984SE |
| K831802 | Life Vac #2191 & 2192LJS · Traditional | 01/11/1984SE |
| K833079 | Centracath #130,135 & 137-HEMOCATH #FOZ · Traditional | 12/29/1983SE |
| K830910 | Manometer Set C.V.P. #S 298/299KRK · Traditional | 04/05/1983SE |
| K822879 | Enteral Nutrition 1KNT · Traditional | 11/16/1982SE |
| K822836 | Microflex-VenofluxFPA · Traditional | 10/15/1982SE |
| K822691 | Vygon Epidural Anaesthesia TrayCAZ · Traditional | 10/15/1982SE |
Questions and answers
When was Vygon Enternal Nutrition Tubes cleared by the FDA?
Vygon Enternal Nutrition Tubes (K820176) received a 510(k) decision of Substantially Equivalent on February 5, 1982, 14 days after the submission was received.
What is the product code of K820176?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.