510(k) K885220
- Device
- PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
- Applicant
- ETHOX CORP.
- 510(k) number
- K885220
- Product code
- KNT
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 1989-09-25
- Date received
- 1988-12-20
- 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
- F JANKOWSKI
- Address
- 251 Seneca St. Buffalo NY US 14204 14204
FDA Registration Numbers#
- 1214422
- 3025772870
- 3030446844
- 3000268902
- 9616088
- 3006538822
- 3018094310
- 3013298431
- 1313046
- 3008044552
- 3004122598
- 9617594
- 1223925
- 3006673317
- 3014421917
- 2029015
- 3014663754
- 3013234390
- 1055236
- 9611590
- 1314417
- 3007285848
- 3031289255
- 3013524793
- 1221485
- 3005609751
- 2183673
- 1526012
- 3017081712
- 3004111573
- 3014656668
- 3014637079
- 3011137372
- 3043226252
- 3010757606
- 3044994889
- 1221765
- 3006271008
- 3006017180
- 3006157842
- 3017607339
- 3006260740
- 1320599
- 3001124136
- 3007697249
- 3034669683
- 3005060859
- 1320894
- 2182291
- 3011088743
- 3042225166
- 3016616327
- 3011237770
- 1037905
- 3010761399
- 1921846
- 3008311916
- 3003903031
- 1024404
- 3010131137
- 9710641
- 9611665
- 1417592
- 9680425
- 3005483737
- 3010155661
- 3010594263
- 3012169247
- 3005669815
- 1000121056
- 1419937
- 3012421607
- 1820334
- 3009632672
- 1056553
- 1293141
- 2024024
- 3008806809
- 9680143
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