510(k) K133465
- Device
- CONSURE STOOL MANAGEMENT SYSTEM
- Applicant
- CONSURE MEDICAL PVT LTD.
- 510(k) number
- K133465
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-06-26
- Date received
- 2013-11-12
- 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
- No
Applicant Contact#
- Contact
- ALAN DONALD
- Address
- 11440 W. Bernardo Ct. Suite 300 San Diego CA US 92127 92127
FDA Registration Numbers#
- 9611665
- 2518417
- 9681477
- 9611594
- 9611590
- 3004122598
- 8030107
- 3005099803
- 1422634
- 2431014
- 3005060859
- 3008570882
- 3005533818
- 1048735
- 3022964615
- 1221765
- 1214422
- 1313046
- 1647149
- 3011270181
- 3013298431
- 3031289255
- 1000317571
- 3002807314
- 1314417
- 3003915875
- 1221019
- 8040607
- 9616088
- 2032112
- 3010280860
- 1649518
- 3009746061
- 3017607339
- 1319639
- 3006606901
- 2320961
- 3016785268
- 3010761399
- 3006538822
- 2243072
- 9680143
- 3010757606
- 2029015
- 3016616327
- 3009211636
- 2016945
- 3031190571
- 3010452421
- 2518902
- 3009247326
- 1213809
- 3045857302
- 1043214
- 8022978
- 1066607
- 1000121056
- 3009698186
- 1047429
- 3006157842
- 3009888344
- 1526854
- 3012568936
- 3011324393
- 3017961114
- 3014663754
- 1058397
- 3034669683
- 2126666
- 3007014520
- 3006673317
- 3020417125
- 3010400865
- 9612030
- 2245270
- 1423662
- 2528981
- 1423537
- 3001124136
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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