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FDA 510(k)

SCOUT MD Surgical Guidance System

K-Number: K231468 · 2024-02-12

ApplicantMerit Medical System, Inc.
Decision Date2024-02-12
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCOUT MD Surgical Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical System, Inc.. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K231468. 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 2024-02-12. The listed applicant is Merit Medical System, Inc.. The 510(k) number is K231468.

When did SCOUT MD Surgical Guidance System receive FDA 510(k) clearance?

SCOUT MD Surgical Guidance System received FDA 510(k) clearance on 2024-02-12, under 510(k) number K231468.

Who is the listed applicant for SCOUT MD Surgical Guidance System?

The FDA 510(k) record lists Merit Medical System, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCOUT MD Surgical Guidance System?

The FDA product code for SCOUT MD Surgical Guidance System is NEU.

Other records listing Merit Medical System, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252527Surfacer Inside-Out Access Catheter SystemK230636Maestro MicrocatheterK212817Merit Siege Vascular PlugK193571Go2Wire Guide Wire

Related Devices (Code: NEU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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