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Surgiscan Scanner

by Norcross Scientific

510(k) K952299

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK952299 Date17 Jul 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Surgiscan Scanner is a Powered Laser Surgical Instrument (Product Code GEX) designed for use in general and plastic surgery procedures. It employs laser technology to perform precise surgical tasks, including tissue ablation, marking, or coagulation, under controlled conditions.

This device is supplied as a reusable medical instrument and is intended for use in sterile surgical environments. It has been granted FDA 510(k) clearance under the Traditional pathway, with a decision date of July 17, 1995, and is classified under regulation 878.4810. No specific MRI safety or sterility classification is stated in the available data.

Questions

AI-generated answers, 19 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 types of surgical procedures is the Surgiscan Scanner primarily used for, and how does it function in those settings?

    The Surgiscan Scanner is designed for general and plastic surgery procedures, where it employs laser technology to perform precise tasks like tissue ablation, marking, or coagulation. Its controlled laser function allows surgeons to achieve accuracy in procedures where traditional tools might be less effective, such as delicate tissue manipulation or marking skin for incisions.

  • Is the Surgiscan Scanner intended for single-use or reusable applications, and what does this mean for maintenance in a surgical setting?

    The Surgiscan Scanner is explicitly described as a reusable medical instrument, meaning it is engineered to withstand repeated sterilization and use in sterile surgical environments. Clinicians must follow proper cleaning, sterilization, and maintenance protocols to ensure its reliability and safety between procedures, as reuse requires rigorous validation of its condition.

  • How is the Surgiscan Scanner supplied, and what considerations should be taken into account when storing or handling it?

    The Surgiscan Scanner is supplied as a reusable device, so it is not packaged for single-use. Since it is intended for sterile surgical environments, storage must adhere to sterile protocols—likely in a clean, dry area with protective packaging until ready for use. Handling should minimize contamination risks, and it must be properly sterilized before each surgical procedure.

  • What regulatory pathway was followed for FDA clearance of the Surgiscan Scanner, and what does this mean for its classification?

    The Surgiscan Scanner received FDA clearance through the Traditional 510(k) pathway, with a decision date of July 17, 1995. This classification under Product Code GEX (Powered Laser Surgical Instruments) means it was determined to be substantially equivalent to a legally marketed device already on the market, ensuring it meets regulatory standards for safety and effectiveness in its intended surgical applications.