510(k) K211072
- Device
- Safety Trocar Cannula
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K211072
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-27
- Date received
- 2021-04-12
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Lingling Guo
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers
- 3005670221
- 1423662
- 3011802696
- 3010972758
- 1450662
- 3036773433
- 1825146
- 9680934
- 3007697249
- 3014637079
- 3010280860
- 1423507
- 3026671998
- 1221485
- 1480288
- 3025772870
- 3003903031
- 3013234390
- 3006131984
- 1320599
- 1526854
- 3007766601
- 3017607339
- 2183744
- 3018167761
- 1222168
- 3013188547
- 8040607
- 3004122598
- 3012568936
- 3006260740
- 3020417125
- 3018507299
- 3009247326
- 2032098
- 1030451
- 3006271008
- 3005674464
- 1119193
- 3006157842
- 3008311916
- 8044169
- 3018116884
- 2320961
- 1718873
- 3005012805
- 3030447506
- 8010042
- 3016785268
- 2016945
- 3001124136
- 3013557562
- 3012441529
- 3010131137
- 3011987967
- 1423537
- 1221019
- 1820334
- 3008808123
- 3031289255
- 3005099803
- 3013298431
- 3009558349
- 2126666
- 3003915875
- 2024024
- 3002807314
- 3006673317
- 3004194523
- 1293141
- 1018233
- 9680143
- 1024404
- 3008810357
- 3013524793
- 3006606901
- 8022210
- 2080225
- 1223925
- 1828132
- 3006538822
- 3004904811
- 1037905
- 1422634
- 3014926389
- 3006161756
- 3014656749
- 9611590
- 8030107
- 1043214
- 1000317571
- 3009632672
- 9618003
- 3012421607
- 3005669815
- 1055236
- 3010155661
- 1649518
- 3042225166
- 3017961114
- 3010594263
- 3008570882
- 3015173212
- 3016616327
- 3014656668
- 1213809
- 3017059666
- 3030708724
- 3005060859
- 1713468
- 2029015
- 3014579161
- 9611594
- 3017081712
- 1417592
- 1928237
- 1058397
- 3011299837
- 1319639
- 3012881740
- 3008044552
- 2245270
- 9611665
- 1056553
- 3007285848
- 9681477
- 3007289408
- 3011324393
- 3011270181
- 3012169247
- 3010761399
- 3005609751
- 3011088743
- 2030624
- 3030446844
- 3012494290
- 2182291
- 1921846
- 3035642068
- 3005580113
- 3022964615
- 3005210579
- 2032112
- 1623486
- 3016761372
- 1647149
- 1066607
- 2518417
- 3009888344
- 1223004
- 2133810
- 3010273872
- 3003627840
- 3005483737
- 1220477
- 3006017180
- 3005533818
- 1047429
- 3011237770
- 3034669683
- 3010958377
- 1643817
- 3012481535
- 1526012
- 9616088
- 1314417
- 3008806809
- 3016171914
- 2029275
- 3018366470
- 1911916
- 2243072
- 2025851
- 9681260
- 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
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 |