Edi Catheter ENFit
FDA 510(k) K153688 · Maquet Critical Care AB
510(k) numberK153688
Submission
- Device name
- Edi Catheter ENFit
- Applicant
- Maquet Critical Care AB
Solna, SE - Received
- December 23, 2015
- Decision date
- March 2, 2017
- 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 |
|---|---|---|
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…PIF · Traditional | 08/26/2026SE |
| K230173 | Servo-air Lite Ventilator SystemMNT · Traditional | 07/06/2023SE |
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…CBK · Traditional | 04/20/2021SE |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemBSZ · Traditional | 03/18/2020SE |
| K182862 | Servo GuardCAH · Traditional | 10/21/2019SE |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBK · Traditional | 03/19/2019SE |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40BSZ · Abbreviated | 03/29/2017SE |
| K151814 | SERVO-U Ventilator System, SERVO-n Ventilator SystemCBK · Traditional | 12/21/2015SE |
| K153461 | Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire…KNT · Special | 12/11/2015SE |
| K123149 | Servo-I Ventilator SystemCBK · Abbreviated | 06/20/2014SE |
Questions and answers
When was Edi Catheter ENFit cleared by the FDA?
Edi Catheter ENFit (K153688) received a 510(k) decision of Substantially Equivalent on March 2, 2017, 435 days after the submission was received.
What is the product code of K153688?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.