Safety Trocar Cannula
FDA 510(k) K211072 · Boston Scientific Corporation
510(k) numberK211072
Submission
- Device name
- Safety Trocar Cannula
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- April 12, 2021
- Decision date
- April 27, 2021
- 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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| 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 |
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| 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 |
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| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
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| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
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Questions and answers
When was Safety Trocar Cannula cleared by the FDA?
Safety Trocar Cannula (K211072) received a 510(k) decision of Substantially Equivalent on April 27, 2021, 15 days after the submission was received.
What is the product code of K211072?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.