TubeClear System
FDA 510(k) K172556 · Actuated Medical, Inc.
510(k) numberK172556
Submission
- Device name
- TubeClear System
- Applicant
- Actuated Medical, Inc.
Bellefonte, PA, US - Received
- August 24, 2017
- Decision date
- June 29, 2018
- 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
Other 510(k)s with product code KNT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100FDS · Traditional | 10/31/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | 10/04/2024SE |
| K231254 | GripTract-GI Endoscopic Tissue ManipulatorFDF · Traditional | 11/03/2023SE |
| K220890 | IO Needle Safety SheathFMI · Traditional | 10/31/2022SE |
| K200646 | TubeClear SystemKNT · Traditional | 12/04/2020SE |
| K163092 | TubeClear Control Box and Clearing StemKNT · Traditional | 11/30/2016SE |
| K131052 | Tubeclear Model 101 (with New Clearing Stem Ne and G Models)KNT · Traditional | 08/16/2013SE |
| K123659 | Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear)KNT · Special | 12/20/2012SE |
| K121571 | TubeclearKNT · Traditional | 06/13/2012SE |
Questions and answers
When was TubeClear System cleared by the FDA?
TubeClear System (K172556) received a 510(k) decision of Substantially Equivalent on June 29, 2018, 309 days after the submission was received.
What is the product code of K172556?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.