510(k) K821231
- Device
- VIVONEX TUNGSTEN TIP TUBE PLACEMENT
- Applicant
- NORWICH EATON PHARMACEUTICALS, INC.
- 510(k) number
- K821231
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-10
- Date received
- 1982-04-27
- 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
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3018507299
- 3015443199
- 1417592
- 8030107
- 3005609751
- 3005580113
- 3004550973
- 3006157842
- 9612030
- 8022978
- 3009698186
- 3009632672
- 1314417
- 3010757606
- 3012568936
- 1000121056
- 2029275
- 3004111573
- 3010041511
- 3005669815
- 2126666
- 2518417
- 1820334
- 3025772870
- 3004122598
- 2183673
- 1647149
- 3031190571
- 3018116884
- 3004365956
- 1718873
- 1643817
- 2431014
- 1058397
- 3006606901
- 1000317571
- 1048735
- 1223925
- 1450662
- 3011237770
- 3041276591
- 3017140456
- 3005012805
- 2032098
- 3006795797
- 3043226252
- 3011299837
- 3030446844
- 1221765
- 3005674464
- 1713468
- 3005483737
- 1018233
- 1424263
- 3006538822
- 1119193
- 3010273872
- 9681572
- 2024024
- 9611594
- 9616088
- 1422634
- 2182291
- 3008311916
- 3030708724
- 2024311
- 3020417125
- 3006131984
- 3012441529
- 3011137372
- 1649518
- 1056553
- 9610694
- 1213809
- 3006260740
- 2133810
- 3022964615
- 3012494290
- 1480288
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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