510(k) K230206
- Device
- Entarik Feeding Tube System; Entarik Feeding Tube
- Applicant
- Gravitas Medical, Inc.
- 510(k) number
- K230206
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-24
- Date received
- 2023-01-25
- Regulation
- 876.5980
- Classification name
- Tubes, Gastrointestinal (And Accessories)
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Saheel Sutaria
- Address
- 101 Mississippi, St. San Francisco CA US 94107 94107
FDA Registration Numbers
- 3005670221
- 1423662
- 3011802696
- 3010972758
- 1450662
- 3036773433
- 1825146
- 9680934
- 3007697249
- 3014637079
- 3010280860
- 1423507
- 3026671998
- 1221485
- 1480288
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- 1718873
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- 8010042
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- 2126666
- 3003915875
- 2024024
- 3002807314
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- 3006161756
- 3014656749
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- 8030107
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- 1000317571
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- 3005669815
- 1055236
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- 3042225166
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- 3011270181
- 3012169247
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- 3005609751
- 3011088743
- 2030624
- 3030446844
- 3012494290
- 2182291
- 1921846
- 3035642068
- 3005580113
- 3022964615
- 3005210579
- 2032112
- 1623486
- 3016761372
- 1647149
- 1066607
- 2518417
- 3009888344
- 1223004
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- 2029275
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- 1911916
- 2243072
- 2025851
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- 8020785
- 1048735
- 3009291251
- 2024311
- 2431014
- 3004111573
- 3006795797
- 9680425
- 3010757606
- 9612030
- 3015479927
- 3002808467
- 3000268902
- 3006606984
- 8022978
- 2518902
- 1313046
- 3014421917
- 9610694
- 3011707784
- 3010041511
- 3017140456
- 3031190571
- 9610849
- 1054241
- 3004550973
- 1214422
- 9681572
- 3015237508
- 3043226252
- 3009211636
- 3009746061
- 3006082230
- 2183673
- 1221765
- 3010331226
- 9710641
- 9617594
- 1000121056
- 3011137372
- 3009265194
- 3004365956
- 2011171
- 3010400865
- 1419937
- 1219930
- 1424263
- 2528981
- 3007014520
- 3018094310
- 3005987240
- 3009698186
- 3010452421
- 1320894
- 3015443199
- 3014663754
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025-04-10 |
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| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | Reshape Lifesciences | 2024-05-16 |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | 2024-05-06 |
| K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. | 2024-04-17 |
| K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | Endolumik | 2024-02-08 |
| K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | 2024-01-26 |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023-12-18 |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | Endolumik, Inc. | 2023-03-03 |