Stomach Tube
FDA 510(k) K162340 · Well Lead Medical Co., Ltd.
510(k) numberK162340
Submission
- Device name
- Stomach Tube
- Applicant
- Well Lead Medical Co., Ltd.
Guangzhou, CN - Received
- August 22, 2016
- Decision date
- October 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
| K250389 | XNY Disposable Gastric Calibration TubeKNT · Traditional | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 04/10/2025SE |
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| K242336 | hygh-tec Drainage IIKNT · Traditional | Amb Medtec | 01/17/2025SE |
| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
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| K241185 | CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional | Avanos Medical, Inc. | 10/25/2024SE |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | Avanos Medical, Inc. | 06/06/2024SE |
| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | 03/05/2025SE |
| K220722 | PVC Hydrophilic Urethral CatheterEZD · Traditional | 05/22/2023SE |
| K220036 | Wellead Ureteral CatheterKOD · Traditional | 12/16/2022SE |
| K211543 | Wei Nasal Jet TubeBTR · Traditional | 07/21/2022SE |
| K211814 | Wellead Endoscopic SealODC · Traditional | 01/14/2022SE |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature SensorEZL · Special | 04/08/2021SE |
| K203119 | ClearPetra Suction-Evacuation SheathFED · Special | 12/09/2020SE |
| K182739 | Endotracheal Tube with Evacuation LumenBTR · Special | 12/11/2019SE |
| K160801 | Well Lead Extraction BagGCJ · Traditional | 11/29/2016SE |
| K161110 | ClearPetra Suction-Evacuation SheathFED · Traditional | 10/12/2016SE |
Questions and answers
When was Stomach Tube cleared by the FDA?
Stomach Tube (K162340) received a 510(k) decision of Substantially Equivalent on October 11, 2017, 415 days after the submission was received.
What is the product code of K162340?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.