SCOUT BX Delivery System
FDA 510(k) K212882 · Merit Medical Systems, Inc.
510(k) numberK212882
Submission
- Device name
- SCOUT BX Delivery System
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- September 10, 2021
- Decision date
- April 8, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | 12/19/2025SE |
| K250853 | Merit SyringeFMF · Special | 11/04/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | 07/23/2025SE |
| K250909 | Prelude Wave Hydrophilic Sheath IntroducerDYB · Special | 04/25/2025SE |
| K242873 | Ventrax Delivery SystemDQY · Special | 01/15/2025SE |
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Questions and answers
When was SCOUT BX Delivery System cleared by the FDA?
SCOUT BX Delivery System (K212882) received a 510(k) decision of Substantially Equivalent on April 8, 2022, 210 days after the submission was received.
What is the product code of K212882?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.