Device Modification of Enteral Feeding Sets for Gravity and Pump Use
FDA 510(k) K012147 · Zevex, Inc.
510(k) numberK012147
Submission
- Device name
- Device Modification of Enteral Feeding Sets for Gravity and Pump Use
- Applicant
- Zevex, Inc.
Salt Lake City, UT, US - Received
- July 10, 2001
- Decision date
- November 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
| 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.
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| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…FRN · Special | 10/03/2024SE |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…FRN · Traditional | 05/17/2024SE |
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetPIF · Traditional | 01/08/2015SE |
| K131154 | Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral…LZH · Special | 02/12/2014SE |
Questions and answers
When was Device Modification of Enteral Feeding Sets for Gravity and Pump Use cleared by the FDA?
Device Modification of Enteral Feeding Sets for Gravity and Pump Use (K012147) received a 510(k) decision of Substantially Equivalent on November 2, 2001, 115 days after the submission was received.
What is the product code of K012147?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.