Enteral Feeding Bottle
FDA 510(k) K841945 · Superior Plastic Products Corp.
510(k) numberK841945
Submission
- Device name
- Enteral Feeding Bottle
- Applicant
- Superior Plastic Products Corp.
Mchenry, IL, US - Received
- May 11, 1984
- Decision date
- July 26, 1984
- 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 |
|---|---|---|
| K851981 | No. 5300-3 1/2 French Umbilical Vessel Cath. Etc.FOZ · Traditional | 06/18/1985SE |
| K843975 | 9 French 42LONG Polyurethane Graduated Enteric FeKNT · Traditional | 11/20/1984SE |
| K841630 | Enteral Nutrition PumpFRN · Traditional | 06/07/1984SE |
| K841480 | Infection Control ValveBSY · Traditional | 04/25/1984SE |
| K840324 | Silicone Sump Drain 20 & 40 FrenchJCY · Traditional | 04/25/1984SE |
| K840323 | Silicone Suction & Irrigation DrainGBX · Traditional | 04/25/1984SE |
| K833687 | Dispos. Enteric Feeding Tubes W/Safe-TKNT · Traditional | 03/02/1984SE |
| K833947 | Superior Enternal Feeding SystemKNT · Traditional | 02/04/1984SE |
| K820460 | 3.5 & 5.5 Oz. Sodium Chloride SolutionJOL · Traditional | 03/08/1982SE |
| K812312 | Sterile Water 4OZ.JOL · Traditional | 11/13/1981SE |
Questions and answers
When was Enteral Feeding Bottle cleared by the FDA?
Enteral Feeding Bottle (K841945) received a 510(k) decision of Substantially Equivalent on July 26, 1984, 76 days after the submission was received.
What is the product code of K841945?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.