Traditional Length GJ Feeding Device
FDA 510(k) K182804 · Applied Medical Technology, Inc.
510(k) numberK182804
Submission
- Device name
- Traditional Length GJ Feeding Device
- Applicant
- Applied Medical Technology, Inc.
Brecksville, OH, US - Received
- October 2, 2018
- Decision date
- March 1, 2019
- 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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| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | Boehringer Laboratories, LLC | 08/14/2026SE |
| 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 |
| K243228 | Flexi-Seal AIR (with ENFit Connector)KNT · Traditional | Convatec | 03/28/2025SE |
| 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 |
| K241169 | Entarik NI Feeding Tube SystemKNT · Traditional | Gravitas Medical, Inc. | 11/22/2024SE |
| 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 |
More from Degania Silicone , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252438 | Explant ExpressQVS · Traditional | 02/03/2026SE |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage SetKOB · Traditional | 11/01/2024SE |
| K241111 | AMT Suture PasserGCJ · Traditional | 07/05/2024SE |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding DeviceKNT · Traditional | 12/18/2023SE |
| K202539 | Nutriglide(TM) Nasal Feeding TubeKNT · Traditional | 10/29/2020SE |
| K193612 | AMT Suture Delivery SystemKGC · Traditional | 03/12/2020SE |
| K183508 | Micro Transgastric-Jejunal Feeding DeviceKNT · Traditional | 03/29/2019SESK |
| K180026 | Bowel Management Device, Bowel Management Irrigation SetKNT · Traditional | 06/01/2018SESK |
| K170319 | Low Profile Non-Balloon Feeding DeviceKNT · Traditional | 10/06/2017SE |
| K161413 | Low Profile Balloon Feeding DeviceKNT · Traditional | 02/09/2017SE |
Questions and answers
When was Traditional Length GJ Feeding Device cleared by the FDA?
Traditional Length GJ Feeding Device (K182804) received a 510(k) decision of Substantially Equivalent on March 1, 2019, 150 days after the submission was received.
What is the product code of K182804?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.