SCOUT MD Surgical Guidance System— 510(k) K252892

Name: FDA 510(k) clearance K252892
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K252892 for SCOUT MD Surgical Guidance System, Substantially Equivalent on 2025-12-19. Applicant: Merit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Product code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2025-09-11
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K252892

K-number listed on FDA's recall record

Z-0187-2027 — Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EOClass II·Ongoing·Merit Medical Systems, Inc.·20260827

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K252892.

Data sourced from openFDA. This site is unofficial and independent of the FDA.