510(k) K831974
- Device
- STOMACH TUBE LEVIN TUBE
- Applicant
- MEDLINE INDUSTRIES, INC.
- 510(k) number
- K831974
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-07-18
- Date received
- 1983-06-20
- Regulation
- 876.5980
- Classification name
- Tubes, Gastrointestinal (and Accessories)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006131984
- 3010131137
- 3012421607
- 9616088
- 9611590
- 1320599
- 3006606901
- 3008808123
- 3010155661
- 2183673
- 3013188547
- 3018366470
- 3011088743
- 2431014
- 3002807314
- 3031289255
- 2528981
- 2024311
- 3006157842
- 3009698186
- 3010761399
- 3018507299
- 2243072
- 3030447506
- 1424263
- 1480288
- 3017081712
- 3014637079
- 3011137372
- 1419937
- 3010452421
- 1647149
- 1526854
- 3006673317
- 3014656749
- 3001124136
- 3009558349
- 3010958377
- 3007014520
- 1056553
- 3014579161
- 3017961114
- 3025772870
- 3042225166
- 3009247326
- 2011171
- 3034669683
- 3013298431
- 8030107
- 3010400865
- 3008044552
- 9681572
- 3016171914
- 9680425
- 8010042
- 1037905
- 3005533818
- 3011802696
- 3017607339
- 1220477
- 1417592
- 3017059666
- 3004122598
- 1221019
- 2133810
- 3005987240
- 3004904811
- 9610849
- 3044994889
- 3014926389
- 3012169247
- 1649518
- 3000268902
- 1058397
- 1024404
- 1423662
- 3009746061
- 3011237770
- 9680143
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases