Nutri-Cath - Feeding Tube
FDA 510(k) K861090 · Gesco Intl., Inc.
510(k) numberK861090
Submission
- Device name
- Nutri-Cath - Feeding Tube
- Applicant
- Gesco Intl., Inc.
San Antonio, TX, US - Received
- March 24, 1986
- Decision date
- June 18, 1986
- 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 |
|---|---|---|
| K954422 | Per-Q-Cath Mid-LineLJS · Traditional | 12/15/1995SE |
| K940953 | Umbili-Cath-SFOS · Traditional | 08/02/1994SE |
| K940870 | Umbili-CathFOS · Traditional | 08/02/1994SE |
| K940952 | Umbili-Cath-S-DlFOS · Traditional | 07/29/1994SE |
| K941672 | Uri-Cath CatheterGBM · Traditional | 05/16/1994SE |
| K941232 | Thora-CathJOL · Traditional | 05/11/1994SE |
| K940871 | Umbili-Cath-PFOS · Traditional | 04/29/1994SE |
| K931989 | Ventri-CathJXG · Traditional | 07/21/1993SE |
| K926063 | Per-Q-Cath Dressing Change TrayMCY · Traditional | 06/07/1993SEKD |
| K923591 | Pala-NateBTR · Traditional | 03/16/1993SE |
Questions and answers
When was Nutri-Cath - Feeding Tube cleared by the FDA?
Nutri-Cath - Feeding Tube (K861090) received a 510(k) decision of Substantially Equivalent on June 18, 1986, 86 days after the submission was received.
What is the product code of K861090?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.