SCOUT MD Surgical Guidance System
FDA 510(k) K252892 · Merit Medical Systems, Inc.
510(k) numberK252892
Submission
- Device name
- SCOUT MD Surgical Guidance System
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- September 11, 2025
- Decision date
- December 19, 2025
- 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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Questions and answers
When was SCOUT MD Surgical Guidance System cleared by the FDA?
SCOUT MD Surgical Guidance System (K252892) received a 510(k) decision of Substantially Equivalent on December 19, 2025, 99 days after the submission was received.
What is the product code of K252892?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.