ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
FDA 510(k) K234033 · Boehringer Laboratories, LLC
510(k) numberK234033
Submission
- Device name
- ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
- Applicant
- Boehringer Laboratories, LLC
Phoenixville, PA, US - Received
- December 20, 2023
- Decision date
- May 6, 2024
- 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 |
|---|---|---|
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | 08/14/2026SE |
| K243399 | Boehringer Laboratories Liver RetractorGCJ · Traditional | 07/02/2025SE |
| K234145 | ViSiGi 3D Gastric Sizing TubeKNT · Special | 01/26/2024SE |
| K151990 | Tissue Removal SystemGCJ · Traditional | 09/11/2015SE |
| K150781 | Tissue Removal PouchGCJ · Traditional | 06/19/2015SE |
| K130483 | Boehringer Gastric Sizing TubeKNT · Traditional | 03/28/2013SE |
| K061788 | Boehringer Laboratories Suction Pump SystemOMP · Traditional | 07/11/2006SE |
| K060277 | Boehringer Laboratories Suction Pump SystemJCX · Traditional | 03/03/2006SE |
| K020538 | Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 SeriesDWL · Traditional | 05/15/2002SE |
| K014187 | Autovac Orthopedic Autotransfusion SystemCAC · Traditional | 02/06/2002SE |
Questions and answers
When was ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) cleared by the FDA?
ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (K234033) received a 510(k) decision of Substantially Equivalent on May 6, 2024, 138 days after the submission was received.
What is the product code of K234033?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.