Aquarius Nasal Feeding Tube
FDA 510(k) K141753 · Degania Silicone , Ltd.
510(k) numberK141753
Submission
- Device name
- Aquarius Nasal Feeding Tube
- Applicant
- Degania Silicone , Ltd.
Emek Hayarden, IL - Received
- June 30, 2014
- Decision date
- October 16, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PIF – Gastrointestinal Tubes With Enteral Specific Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
To facilitate enteral specific connections.
Other 510(k)s with product code PIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260110 | danumed Extension Set for Gastrostomy ButtonPIF · Traditional | Danumed Medizintechnik GmbH | 09/10/2026SE |
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…PIF · Traditional | Maquet Critical Care AB | 08/26/2026SE |
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) KitPIF · Traditional | Degania Silicone , Ltd. | 03/20/2026SE |
| K242917 | Enteral Drainage System, Enteral Medicine strawPIF · Traditional | HMC Premedical S.p.A. | 06/18/2025SE |
| K250481 | Extension Feeding Set with ENFit ConnectorsPIF · Traditional | SKY Medical, a.s. | 04/18/2025SE |
| K240052 | Disposable Enteral Feeding SetsPIF · Traditional | Beijing L&Z Medical Technology Development Co.… | 07/03/2024SE |
| K233034 | Mobility+ Enteral Feeding System OTCPIF · Traditional | Rockfield Medical | 04/12/2024SE |
| K230326 | ENFit to ENFit Extension SetsPIF · Traditional | Vesco Medical | 11/02/2023SE |
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…PIF · Traditional | Xeridiem Medical Devices, A Spectrum Plastics… | 10/06/2023SE |
| K222773 | Feeding TubePIF · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/17/2023SE |
More from Anhui Tiankang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) KitPIF · Traditional | 03/20/2026SE |
| K233591 | StylusKNT · Traditional | 05/31/2024SE |
| K152246 | Aquarius Stoma Measuring DeviceKNT · Traditional | 06/21/2016SE |
| K143378 | AQUARIUS Gastrostomy Replacement TubeKNT · Special | 12/29/2014SE |
| K141631 | Aquarius Extension Feeding SetKNT · Special | 07/28/2014SESK |
| K132686 | Aquarius Low Profile Gastrostomy Feeding TubeKNT · Traditional | 05/12/2014SESK |
| K131020 | Temperature Sensor CatheterEZL · Special | 05/09/2013SE |
| K122030 | Low Profile Gastrostomy Feeding Tube or Gastrotomey ButtonKNT · Traditional | 09/05/2012SE |
| K103371 | Coude/ or TiemannEZL · Traditional | 03/11/2011SE |
| K070124 | Gastrostomy Replacement Tube, Model 253KNT · Traditional | 05/23/2007SE |
Questions and answers
When was Aquarius Nasal Feeding Tube cleared by the FDA?
Aquarius Nasal Feeding Tube (K141753) received a 510(k) decision of Substantially Equivalent on October 16, 2014, 108 days after the submission was received.
What is the product code of K141753?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.