510(k) K082863
- Device
- DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)
- Applicant
- DYNAREX CORPORATION
- 510(k) number
- K082863
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-09
- Date received
- 2008-09-29
- 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
- JAMES HURLMAN
- Address
- 10 Glenshaw St. Orangeburg NY US 10962 10962
FDA Registration Numbers#
- 3009698186
- 3006271008
- 3015173212
- 9617594
- 1221485
- 1423537
- 2024311
- 1221765
- 2029275
- 2024024
- 3011987967
- 3005533818
- 1056553
- 3006538822
- 2528981
- 8010042
- 3014656749
- 3034669683
- 1423662
- 3017607339
- 3007289408
- 3031190571
- 3010400865
- 3011088743
- 8022978
- 3036773433
- 3025772870
- 3002807314
- 3042225166
- 3009265194
- 3010757606
- 3012568936
- 1000121056
- 3011237770
- 3008808123
- 2182291
- 2025851
- 1119193
- 3006260740
- 3018366470
- 3030708724
- 2032112
- 9616088
- 3018094310
- 2011171
- 3017081712
- 2431014
- 1048735
- 3031289255
- 3009247326
- 1319639
- 3011324393
- 2126666
- 1018233
- 1054241
- 3006161756
- 1928237
- 3006082230
- 9680143
- 3009558349
- 3026671998
- 3003915875
- 1423507
- 9680425
- 3007014520
- 3012169247
- 3000268902
- 3017059666
- 1219930
- 3006606984
- 2245270
- 9611665
- 3013188547
- 1313046
- 1220477
- 3013524793
- 3015479927
- 3015443199
- 3005580113
Source Documents#
Other 510(k) Records For Product Code KNT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023-03-24 |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | Endolumik, Inc. | 2023-03-03 |
Legacy Summary#
summary
FDA Review#
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