510(k) K130483
- Device
- BOEHRINGER GASTRIC SIZING TUBE
- Applicant
- BOEHRINGER LABORATORIES, LLC
- 510(k) number
- K130483
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-28
- Date received
- 2013-02-25
- 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
- Yes
Applicant Contact#
- Contact
- CHRISTOPHER RADL, ENGINEERING
- Address
- 300 Thoms Dr. Phoenixville PA US 19460 19460
FDA Registration Numbers#
- 3017140456
- 1422634
- 1314417
- 3012441529
- 3005099803
- 3006538822
- 3006271008
- 3009698186
- 1223925
- 3034669683
- 3005533818
- 3005060859
- 2024311
- 1058397
- 3014663754
- 3006795797
- 1423662
- 1450662
- 3005483737
- 9611665
- 2032112
- 1820334
- 1526012
- 1320599
- 2518417
- 1066607
- 3004365956
- 1221485
- 3036773433
- 3003627840
- 3017961114
- 3009265194
- 3006161756
- 3001124136
- 9680425
- 3007697249
- 3007285848
- 3014421917
- 9611594
- 1048735
- 2243072
- 1526854
- 3035642068
- 1313046
- 3010331226
- 1000121056
- 3004194523
- 2126666
- 2431014
- 3002807314
- 3005674464
- 3030447506
- 3018167761
- 2032098
- 3012481535
- 3018094310
- 3016171914
- 1647149
- 1056553
- 3006673317
- 3031289255
- 3013298431
- 3009632672
- 1649518
- 1828132
- 3009558349
- 3006606984
- 3005580113
- 3031190571
- 1054241
- 3005609751
- 1713468
- 9680143
- 3009888344
- 1911916
- 3030708724
- 3010155661
- 3013234390
- 3014656749
Source Documents#
Other 510(k) Records For Product Code KNT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | C.R. Bard, Inc. | 2026-07-10 |
| 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 |
Legacy Summary#
summary
FDA Review#
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