Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
FDA 510(k) K213174 · Cardinalhealth
510(k) numberK213174
Submission
- Device name
- Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
- Applicant
- Cardinalhealth
Waukegan, IL, US - Received
- September 28, 2021
- Decision date
- May 19, 2022
- 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
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|---|---|---|---|
| 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 |
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| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with…PNR · Special | 12/19/2024SE |
| K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health…FXX · Abbreviated | 07/03/2023SE |
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| K191101 | Kendall NPWT Incision Management Dressing KitOMP · Traditional | 07/31/2020SE |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionPIF · Traditional | 11/07/2019SE |
| K171499 | Occlusion Detection Dressing KitOMP · Traditional | 09/22/2017SE |
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Questions and answers
When was Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection cleared by the FDA?
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (K213174) received a 510(k) decision of Substantially Equivalent on May 19, 2022, 233 days after the submission was received.
What is the product code of K213174?
The FDA product code is PIF – Gastrointestinal Tubes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.