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SCOUT MD Surgical Guidance System

by Merit Medical Systems, Inc.

510(k) K252892

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252892 Date19 Dec 2025ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0187-2027 FDA Class II initiated 27 Aug 2026

    The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NEU
Device class
Class II
Regulation
21 CFR Part 878.4300
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Scout MD Surgical Guidance System is a radiographic marker device used in general and plastic surgery procedures. It is designed to assist in surgical guidance through radiographic imaging.

The device is supplied as a sterile, single-use implantable marker. It is authorized under FDA 510(k) clearance K252892 and is intended for use in clinical settings requiring radiographic localization during surgery.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Scout MD Surgical Guidance System used for?

    The Scout MD Surgical Guidance System is used to assist in surgical guidance through radiographic imaging during general and plastic surgery procedures. It functions as an implantable marker that helps surgeons localize tissue or structures intraoperatively using X-ray or other radiographic modalities, improving precision in marker placement and reducing reliance on external landmarks.

  • How is the Scout MD Surgical Guidance System supplied and is it reusable?

    The device is supplied as a sterile, single-use implantable marker. It is intended for one-time use only and must not be reprocessed or reused, as doing so could compromise sterility, structural integrity, and patient safety. Each unit is individually packaged to maintain sterility until point of use.

  • What regulatory pathway was used for the Scout MD Surgical Guidance System?

    The Scout MD Surgical Guidance System received market authorization through the FDA 510(k) premarket notification pathway, specifically under clearance K252892. It was determined to be substantially equivalent to a predicate device, allowing it to be legally marketed for its intended use in surgical guidance via radiographic imaging.