Feeding Tube
FDA 510(k) K222773 · Anhui Tiankang Medical Technology Co., Ltd.
510(k) numberK222773
Submission
- Device name
- Feeding Tube
- Applicant
- Anhui Tiankang Medical Technology Co., Ltd.
Tianchang, CN - Received
- September 14, 2022
- Decision date
- August 17, 2023
- 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.
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| 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 |
| K223683 | EnteraLoc FlowPIF · Traditional | Vonco Products | 07/10/2023SE |
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Questions and answers
When was Feeding Tube cleared by the FDA?
Feeding Tube (K222773) received a 510(k) decision of Substantially Equivalent on August 17, 2023, 337 days after the submission was received.
What is the product code of K222773?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.