510(k) K881162
- Device
- ENTERA* ENTERAL FEEDING BAG
- Applicant
- SMASH ENT., INC.
- 510(k) number
- K881162
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-06-03
- Date received
- 1988-03-18
- Regulation
- 876.5980
- Classification name
- Tubes, Gastrointestinal (and Accessories)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANET L ZAHN
- Address
- 3585 Lexington Ave. N. Suite 258 Arden Hills MN US 55126 55126
FDA Registration Numbers#
- 3042225166
- 9616088
- 3010452421
- 3012441529
- 3014579161
- 1649518
- 1000317571
- 2032112
- 3009698186
- 3013298431
- 1000121056
- 1222168
- 3011707784
- 1320894
- 3011299837
- 8040607
- 1223925
- 3005987240
- 3013188547
- 3009291251
- 3014421917
- 3011137372
- 9681572
- 3018116884
- 1718873
- 3025772870
- 3011237770
- 1319639
- 3010400865
- 9610849
- 1213809
- 3009746061
- 3014656668
- 3010972758
- 3035642068
- 1221765
- 3008808123
- 3015443199
- 3010280860
- 3010155661
- 3013524793
- 3020417125
- 1056553
- 3005533818
- 2183744
- 3043226252
- 9611594
- 1928237
- 3014663754
- 8030107
- 3014637079
- 2024311
- 3026671998
- 3008044552
- 2182291
- 3006017180
- 3005669815
- 3004365956
- 3010757606
- 3030708724
- 3018094310
- 1820334
- 1526012
- 3012481535
- 3004194523
- 3014926389
- 1526854
- 3011324393
- 3005483737
- 1219930
- 2518902
- 9680425
- 1422634
- 3003627840
- 1825146
- 3022964615
- 1223004
- 3010761399
- 1713468
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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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