Standard Bougie
FDA 510(k) K191885 · Standard Bariatrics
510(k) numberK191885
Submission
- Device name
- Standard Bougie
- Applicant
- Standard Bariatrics
Cincinnati, OH, US - Received
- July 15, 2019
- Decision date
- April 8, 2020
- 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 |
|---|---|---|
| K231603 | Standard Staple-Line Reinforcement (SSLR23)OXC · Traditional | 10/06/2023SE |
| K222085 | Standard Tapered Bougie, 38 Fr.KNT · Traditional | 10/31/2022SE |
| K212728 | Standard Bougie, 38 Fr. and Hand PumpKNT · Special | 09/23/2021SE |
| K210437 | Standard Bougie, 38 Fr.KNT · Traditional | 06/29/2021SE |
| K210278 | Titan SGSGDW · Traditional | 04/28/2021SE |
| K200517 | Standard TrocarGCJ · Traditional | 04/09/2020SE |
| K190788 | Disposable Standard ClampGCJ · Special | 04/18/2019SE |
| K181608 | Disposable Standard ClampGCJ · Traditional | 09/27/2018SE |
| K170379 | Disposable Standard ClampGCJ · Traditional | 07/19/2017SE |
| K161720 | Standard ClampGCJ · Traditional | 10/24/2016SE |
Questions and answers
When was Standard Bougie cleared by the FDA?
Standard Bougie (K191885) received a 510(k) decision of Substantially Equivalent on April 8, 2020, 268 days after the submission was received.
What is the product code of K191885?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.