510(k) K153688
- Device
- Edi Catheter ENFit
- Applicant
- MAQUET CRITICAL CARE AB
- 510(k) number
- K153688
- Product code
- PIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-02
- Date received
- 2015-12-23
- 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
- MIRVA BOOTHE
- Address
- Rontgenvagen 2 Solna SE SE-171 54 SE-171 54
FDA Registration Numbers#
- 1423537
- 3004906872
- 3011987967
- 8010042
- 3034669683
- 3017607339
- 1419562
- 3007289408
- 3031190571
- 3010400865
- 8022978
- 3008058400
- 1000121056
- 3015276780
- 3015997711
- 2025851
- 3018366470
- 2032112
- 3016884033
- 3004784537
- 3017081712
- 3014662855
- 1048735
- 3005458990
- 3009247326
- 3007441619
- 3004472854
- 1225687
- 9680425
- 3007138831
- 3012169247
- 3005580113
- 2029015
- 3007766601
- 3010273872
- 1921846
- 3012881740
- 3016171914
- 3003903031
- 1066607
- 3008806809
- 9610849
- 3005210579
- 3027341532
- 3010972758
- 9612030
- 3003965134
- 3005574598
- 3015462350
- 3014926389
- 3017509841
- 1526012
- 1828132
- 3007590959
- 3008448733
- 3003593728
- 3005674464
- 3014637079
- 1058397
- 3012104670
- 3005099803
- 3013298431
- 3008102042
- 3014656668
- 1722139
- 1417592
- 1000317571
- 9618003
- 3010017366
- 3006673317
- 3010131137
- 3016761372
- 2080225
- 9681260
- 3005670221
- 9613419
- 3014615028
- 3011270181
- 3015433750
- 3008311916
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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