510(k) K882867
- Device
- CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
- Applicant
- CORPAK CO.
- 510(k) number
- K882867
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-21
- Date received
- 1988-07-11
- 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
- ROBERT B EDWARDS
- Address
- 100 Chaddick Dr. Wheeling IL US 60090 60090
FDA Registration Numbers#
- 3017081712
- 3008806809
- 3013557562
- 2032112
- 3013508647
- 1526012
- 1911916
- 8010042
- 9611590
- 3005580113
- 2025851
- 3010400865
- 3008808123
- 3009746061
- 3015173212
- 1320599
- 3006271008
- 1643817
- 3007697249
- 3020417125
- 9618003
- 3006131984
- 1417592
- 3005060859
- 1055236
- 2518417
- 9680934
- 3004550973
- 9612030
- 3013188547
- 1423537
- 3022964615
- 3013234390
- 2243072
- 3010155661
- 3005099803
- 1058397
- 1718873
- 3007766601
- 2133810
- 3004904811
- 3017961114
- 3017059666
- 2032098
- 3042225166
- 1825146
- 1018233
- 3005670221
- 3013524793
- 1424263
- 3035642068
- 3008044552
- 1647149
- 3005987240
- 1037905
- 3002807314
- 3016171914
- 3015443199
- 3017140456
- 1828132
- 3018167761
- 2183744
- 3014637079
- 3025772870
- 3002808467
- 3044994889
- 2431014
- 3030708724
- 3009558349
- 3006161756
- 3026671998
- 1313046
- 3011137372
- 3011270181
- 2126666
- 9710641
- 3009291251
- 1213809
- 2080225
Source Documents#
510(k) summary PDF not indicated by FDA
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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