510(k) K083685
- Device
- ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285
- Applicant
- MRI MANUFACTURING AND RESEARCH, INC.
- 510(k) number
- K083685
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-06-25
- Date received
- 2008-12-12
- 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
- Yes
Applicant Contact#
- Contact
- SUZANNE DEW
- Address
- 4700 S. Overland Dr. Tucson AZ US 85714 85714
FDA Registration Numbers#
- 8022978
- 3009211636
- 3034669683
- 1825146
- 3030447506
- 3010958377
- 2320961
- 1018233
- 3018507299
- 1419937
- 1911916
- 3004904811
- 3005580113
- 3007285848
- 2011171
- 9612030
- 8022210
- 3020417125
- 2183673
- 9680143
- 3010041511
- 3006131984
- 3010972758
- 3008810357
- 3006161756
- 3008806809
- 3016616327
- 3012169247
- 1066607
- 3010131137
- 3008808123
- 1623486
- 3015173212
- 1314417
- 3018167761
- 3004111573
- 1000317571
- 1000121056
- 3010400865
- 3010594263
- 2030624
- 8020785
- 9611594
- 3015443199
- 3036773433
- 3015479927
- 2025851
- 3001124136
- 3031289255
- 3011324393
- 2245270
- 1054241
- 3006157842
- 3031190571
- 2182291
- 1293141
- 2183744
- 9611665
- 2126666
- 3005483737
- 9680425
- 9617594
- 3042225166
- 3006673317
- 1047429
- 3010280860
- 1450662
- 8040607
- 3005674464
- 3002808467
- 2024024
- 3012568936
- 3011987967
- 3005669815
- 1213809
- 9681572
- 1928237
- 3006260740
- 3017059666
Source Documents#
Other 510(k) Records For Product Code KNT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025-04-10 |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | 2025-03-28 |
| K242336 | hygh-tec Drainage II | Amb Medtec | 2025-01-17 |
| K242901 | ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) | Tools For Surgery, LLC | 2025-01-10 |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024-11-22 |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. | 2024-10-25 |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. | 2024-06-06 |
| K233591 | Stylus | Degania Silicone , Ltd. | 2024-05-31 |
| 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 |
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023-03-24 |
Legacy Summary#
summary
FDA Review#
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