SCOUT MD Surgical Guidance System
K-Number: K252892 · 2025-12-19
ApplicantMerit Medical Systems, Inc.
Decision Date2025-12-19
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SCOUT MD Surgical Guidance System is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-12-19 under approval number K252892. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SCOUT MD Surgical Guidance System?
SCOUT MD Surgical Guidance System is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K252892.
When was SCOUT MD Surgical Guidance System approved by the FDA?
SCOUT MD Surgical Guidance System received FDA 510(k) clearance on 2025-12-19, under approval number K252892.
What company makes SCOUT MD Surgical Guidance System?
SCOUT MD Surgical Guidance System is manufactured by Merit Medical Systems, Inc..
What is the FDA product code for SCOUT MD Surgical Guidance System?
The FDA product code for SCOUT MD Surgical Guidance System is NEU.
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Official Source
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