Ivac Keofeed II Polyurethane Feeding Tube
FDA 510(k) K850182 · Y
510(k) numberK850182
Submission
- Device name
- Ivac Keofeed II Polyurethane Feeding Tube
- Applicant
- Y
San Diego, CA, US - Received
- January 18, 1985
- Decision date
- March 19, 1985
- 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 |
|---|---|---|
| K955846 | Model 2082 Temp Plus III Thermometer/Model 2087 Temp Plus III Wall Mount ThermometerFLL · Traditional | 10/01/1996SE |
| K960280 | Ivac Needle Free Valve Administration SetsFPA · Traditional | 04/04/1996SE |
| K953225 | Ivac Ball Valce Admin. SetsFPA · Traditional | 09/27/1995SE |
| K934095 | Ivac Vented Syringe Adapter Administration SetsFPA · Traditional | 08/10/1994SE |
| K940897 | Ivac Needleless Infection Valve Administration SetFPA · Traditional | 06/22/1994SE |
| K931550 | Ez Administration SetFPA · Traditional | 01/10/1994SE |
| K932544 | Ivac Space Saver Volumetric Pump, Model 599FRN · Traditional | 10/12/1993SE |
| K931549 | Model EZ-1 Sing CHAN/EZ-2 Dual Channel Infus PumpFRN · Traditional | 10/12/1993SE |
| K922115 | Ivac Needleless Injection ValveFPA · Traditional | 10/12/1993SE |
| K930781 | Infusion PumpFRN · Traditional | 08/19/1993SE |
Questions and answers
When was Ivac Keofeed II Polyurethane Feeding Tube cleared by the FDA?
Ivac Keofeed II Polyurethane Feeding Tube (K850182) received a 510(k) decision of Substantially Equivalent on March 19, 1985, 60 days after the submission was received.
What is the product code of K850182?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.