510(k) K234033
- Device
- ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
- Applicant
- Boehringer Laboratories, LLC
- 510(k) number
- K234033
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-06
- Date received
- 2023-12-20
- 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
- Ondrej Nikel
- Address
- 300 Thoms Dr. Phoenixville PA US 19460 19460
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
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 |
| 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 |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | Endolumik, Inc. | 2023-03-03 |