Bard Dignishield Stool Management System
FDA 510(k) K133251 · C.R. Bard, Inc.
510(k) numberK133251
Submission
- Device name
- Bard Dignishield Stool Management System
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- October 22, 2013
- Decision date
- May 9, 2014
- Decision
- Unknown (SESK)
- 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 |
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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 |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Bard Dignishield Stool Management System cleared by the FDA?
Bard Dignishield Stool Management System (K133251) received a 510(k) decision of Unknown on May 9, 2014, 199 days after the submission was received.
What is the product code of K133251?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.