510(k) K950017
- Device
- FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM
- Applicant
- ROSS PRODUCTS
- 510(k) number
- K950017
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-14
- Date received
- 1995-01-03
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEWL H HANEY
- Address
- 625 Cleveland Ave. Columbus OH US 43215 43215
FDA Registration Numbers#
- 3017140456
- 3012568936
- 3017607339
- 3006082230
- 1424263
- 1066607
- 3012421607
- 3030446844
- 3010761399
- 9680934
- 2025851
- 3006157842
- 1623486
- 3010452421
- 3018116884
- 3044994889
- 3007014520
- 9610694
- 3004111573
- 2133810
- 3010280860
- 3006606984
- 3042225166
- 1056553
- 1526012
- 2011171
- 2518902
- 8022978
- 3031289255
- 2126666
- 3015237508
- 8044169
- 3005099803
- 3043226252
- 3009632672
- 9616088
- 1037905
- 3012441529
- 9680425
- 3011137372
- 1313046
- 3015443199
- 3009265194
- 3015479927
- 2183673
- 1043214
- 3002808467
- 8022210
- 3000268902
- 1713468
- 3012169247
- 3036773433
- 3005210579
- 3018507299
- 1214422
- 3011237770
- 3014579161
- 3035642068
- 1221765
- 3010041511
- 3010331226
- 2032098
- 2518417
- 3011270181
- 3014656668
- 9611665
- 3020417125
- 3008570882
- 3011707784
- 1911916
- 3018366470
- 1319639
- 2024024
- 9611594
- 1213809
- 3005669815
- 3022964615
- 3017961114
- 1054241
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| 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 |
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023-03-24 |
Legacy Summary#
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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