510(k) K101199
- Device
- GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,
- Applicant
- MAQUET CRITICAL CARE AB
- 510(k) number
- K101199
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-08-27
- Date received
- 2010-04-29
- 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
- WHITNEY TORNING
- Address
- 45 Borbour Pond Dr. Wayne NJ US 07470 07470
FDA Registration Numbers#
- 3005210579
- 3008810357
- 1223004
- 2518902
- 1066607
- 3010041511
- 3009247326
- 3030446844
- 3004194523
- 3006082230
- 3015173212
- 3006161756
- 3005533818
- 1450662
- 2016945
- 3012568936
- 3016785268
- 2030624
- 1828132
- 3008570882
- 1222168
- 3014579161
- 1313046
- 3017140456
- 2518417
- 8022978
- 3011802696
- 3009211636
- 1214422
- 9681572
- 3022964615
- 2025851
- 3005099803
- 3018366470
- 3005060859
- 3010958377
- 3041276591
- 3014637079
- 3034669683
- 1018233
- 3010280860
- 3003915875
- 9610694
- 3006131984
- 8010042
- 1911916
- 3013557562
- 1643817
- 3043226252
- 1423507
- 3011137372
- 3017961114
- 3010273872
- 3004122598
- 3044994889
- 3010131137
- 3018507299
- 1030451
- 1054241
- 3020417125
- 3004550973
- 3014656749
- 3007014520
- 1219930
- 3014656668
- 3008311916
- 1921846
- 9611665
- 3001124136
- 3009265194
- 3004904811
- 3005609751
- 9617594
- 9610849
- 3005674464
- 3005670221
- 1055236
- 1047429
- 1056553
Source Documents#
Other 510(k) Records For Product Code KNT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262038 | danumed StomaMeter | Danumed Medizintechnik GmbH | 2026-09-30 |
| 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 |
Legacy Summary#
summary
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