510(k) K180708
- Device
- Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube With ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit With ENFit Connection, PromaX Low P
- Applicant
- Xeridiem Medical Devices, A Spectrum Plastics Group Company
- 510(k) number
- K180708
- Product code
- PIF
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2018-10-18
- Date received
- 2018-03-19
- Regulation
- 876.5980
- Classification name
- Gastrointestinal Tubes With Enteral Specific Connectors
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Steve Murray
- Address
- 4700 S. Overland Dr. Tucson AZ US 85714 85714
FDA Registration Numbers#
- 8022978
- 3010017366
- 3034669683
- 3015433750
- 3005580113
- 3003593728
- 9612030
- 3010972758
- 3008806809
- 3012169247
- 1066607
- 3010131137
- 1000317571
- 9613419
- 1000121056
- 3010400865
- 3008058400
- 3027341532
- 2025851
- 3001124136
- 3014016859
- 3031190571
- 3015462350
- 3017509841
- 9680425
- 3006673317
- 3003965134
- 3008102042
- 3007590959
- 3005674464
- 3011987967
- 1419562
- 3004784537
- 3010273872
- 3012104670
- 3005670221
- 3005458990
- 1921846
- 3004906872
- 3013557562
- 3016884033
- 1722139
- 3009247326
- 1417592
- 9610849
- 3008311916
- 1225687
- 3016761372
- 3014421917
- 3007138831
- 3017081712
- 3008044552
- 1828132
- 2032112
- 1058397
- 1423537
- 8010042
- 2029015
- 3016171914
- 3018366470
- 3015997711
- 2080225
- 3014637079
- 3015276780
- 9618003
- 3017607339
- 3007766601
- 3003903031
- 3013298431
- 3008448733
- 3011270181
- 3009988302
- 9681260
- 3004472854
- 1048735
- 3007289408
- 3014615028
- 3005210579
- 3005099803
- 3014656668
Source Documents#
Other 510(k) Records For Product Code PIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone , Ltd. | 2026-03-20 |
| K242917 | Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. | 2025-06-18 |
| K250481 | Extension Feeding Set with ENFit™ Connectors | SKY Medical, a.s. | 2025-04-18 |
| K240052 | Disposable Enteral Feeding Sets | Beijing L&Z Medical Technology Development Co., Ltd. | 2024-07-03 |
| K233034 | Mobility+ Enteral Feeding System OTC | Rockfield Medical | 2024-04-12 |
| K230326 | ENFit to ENFit Extension Sets | Vesco Medical | 2023-11-02 |
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2023-10-06 |
| K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 |
| K223683 | EnteraLoc Flow | Vonco Products | 2023-07-10 |
| K222678 | Mobility+ Enteral Feeding System | Rockfield Medical | 2022-10-27 |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | 2022-06-09 |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2022-05-19 |
| K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2022-01-20 |
| K210854 | Enteral Feeding Set | Kb Medical (Group), Inc. | 2021-11-16 |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair Lgl | 2021-11-02 |
Legacy Summary#
summary
FDA Review#
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