510(k) K080679
- Device
- MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
- Applicant
- VIASYS MEDSYSTEMS
- 510(k) number
- K080679
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-27
- Date received
- 2008-03-10
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHANIE WASIELEWSKI
- Address
- 100 Chaddick Dr. Wheeling IL US 60090 60090
FDA Registration Numbers#
- 1223925
- 3017140456
- 1213809
- 3008806809
- 9612030
- 3013557562
- 3030708724
- 3012881740
- 8040607
- 8030107
- 1820334
- 3009888344
- 3004122598
- 3005012805
- 1718873
- 3009291251
- 3012494290
- 1056553
- 3014926389
- 9610849
- 3041276591
- 2243072
- 1319639
- 3004550973
- 3007014520
- 8022210
- 3006538822
- 3008810357
- 3014663754
- 1214422
- 9616088
- 3012421607
- 3014637079
- 1220477
- 3010452421
- 3014421917
- 2528981
- 3018366470
- 3011237770
- 2024311
- 1018233
- 3004365956
- 3012568936
- 1911916
- 1480288
- 3002808467
- 9617594
- 3015237508
- 1222168
- 3007766601
- 3011137372
- 1828132
- 3017081712
- 3009746061
- 2032098
- 1423507
- 3009247326
- 3006017180
- 9611665
- 3013298431
- 3009698186
- 1043214
- 1423537
- 3010280860
- 2518902
- 3006131984
- 3031289255
- 3003903031
- 3010273872
- 3010400865
- 3009211636
- 9611594
- 2133810
- 3005060859
- 3006673317
- 9680143
- 3009558349
- 3010958377
- 2183744
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KNT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | 2026-08-14 |
| 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 |
Legacy Summary#
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FDA Review#
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