Feeding Tube
FDA 510(k) K833591 · Medovations, Inc.
510(k) numberK833591
Submission
- Device name
- Feeding Tube
- Applicant
- Medovations, Inc.
Mchenry, IL, US - Received
- October 12, 1983
- Decision date
- November 28, 1983
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K142068 | Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating…OCX · Traditional | 03/10/2015SE |
| K002363 | Medovations Esophageal DilatorKNQ · Traditional | 11/01/2000SE |
| K972119 | Maloney Bouge (1210-XX)/HURST Bougie (1212-XX)FAT · Traditional | 02/02/1998SE |
| K924646 | Over the Guidewire Dilatation SystemKNQ · Traditional | 12/05/1994SE |
| K913678 | Trocar CatheterKGY · Traditional | 12/16/1991SE |
| K905478 | Yankauer Suction DeviceMDM · Traditional | 12/19/1990SE |
| K874309 | Urethal CatheterKNX · Traditional | 12/07/1987SE |
| K864963 | Stomach Evaculator - Ewald StyleKOA · Traditional | 10/14/1987SE |
| K864962 | Oberto Mouth PropJXL · Traditional | 02/19/1987SE |
| K864964 | 5 - in - 1 ConnectorGAZ · Traditional | 01/20/1987SE |
Questions and answers
When was Feeding Tube cleared by the FDA?
Feeding Tube (K833591) received a 510(k) decision of Substantially Equivalent on November 28, 1983, 47 days after the submission was received.
What is the product code of K833591?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.