510(k) K946249
- Device
- BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K946249
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-12-11
- Date received
- 1994-12-23
- 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
- JOHN A DELUCIA
- Address
- 200 Ames Pond Dr. Tewksbury MA US 01876 01876
FDA Registration Numbers#
- 1221765
- 1718873
- 1423507
- 9611590
- 2133810
- 3009247326
- 3009698186
- 2016945
- 3011802696
- 3010972758
- 3011237770
- 3007766601
- 3006606984
- 3034669683
- 1000317571
- 1928237
- 3006795797
- 3017961114
- 3005674464
- 1220477
- 3044994889
- 3006606901
- 3001124136
- 3010280860
- 3015443199
- 3000268902
- 3012441529
- 3009558349
- 2030624
- 1526012
- 1820334
- 1219930
- 9680143
- 3004194523
- 1048735
- 3005483737
- 2245270
- 1423537
- 8010042
- 3012169247
- 3014421917
- 1043214
- 1221019
- 3010273872
- 1030451
- 3016785268
- 3015479927
- 3003915875
- 2080225
- 3014637079
- 3018507299
- 3010757606
- 3018094310
- 9680425
- 3010594263
- 2243072
- 3014579161
- 3013508647
- 3045857302
- 3004550973
- 3014663754
- 2024311
- 3008311916
- 1647149
- 3008810357
- 1320894
- 1643817
- 3031289255
- 9681572
- 3009888344
- 3011137372
- 3005669815
- 3005060859
- 1055236
- 1623486
- 9611665
- 1293141
- 2126666
- 3031190571
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#
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FDA Review#
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