510(k) K961884
- Device
- CATH CADDIE
- Applicant
- MARK-CLARK
- 510(k) number
- K961884
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-08-01
- Date received
- 1996-05-15
- 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
- KEN WEDDLE
- Address
- 3601 W. 29th St. Topka KS US 66614 66614
FDA Registration Numbers#
- 3008044552
- 3009247326
- 2518902
- 9681477
- 2024311
- 1713468
- 3009558349
- 3005580113
- 3005012805
- 9680934
- 3016616327
- 1319639
- 2182291
- 3018094310
- 1054241
- 2528981
- 3042225166
- 3011088743
- 3010958377
- 9681260
- 1718873
- 8022978
- 3003915875
- 3010400865
- 3006606984
- 1223004
- 3005609751
- 3015173212
- 3015237508
- 3010331226
- 8040607
- 1293141
- 3014637079
- 2126666
- 3011324393
- 1825146
- 9616088
- 2183673
- 3008810357
- 3014656749
- 3006082230
- 3044994889
- 3006271008
- 9612030
- 3004194523
- 3035642068
- 3009211636
- 3010761399
- 3003627840
- 1649518
- 3007285848
- 1424263
- 3022964615
- 3017140456
- 1000121056
- 1320599
- 1422634
- 1055236
- 9681572
- 3017961114
- 3013234390
- 2032098
- 9611594
- 3017059666
- 3034669683
- 3045857302
- 1047429
- 1058397
- 9610694
- 2243072
- 1213809
- 3004111573
- 1423507
- 3005674464
- 1643817
- 1623486
- 3006131984
- 2016945
- 3017081712
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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