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Matrix 101 Negative Galvanic Generator

by Prn Medical

510(k) K844816

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 NumberK844816 Date4 Apr 1985ClearedStatusActive

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

This device is an electrosurgical cutting and coagulation accessory, as defined by its classification name and product code GEI. It functions as a negative galvanic generator intended for use in general and plastic surgery procedures.

It is supplied as a reusable device and received FDA 510(k) clearance under number K844816 on April 4, 1985, following a traditional review process. The device was submitted by Prn Medical and is classified for use in general and plastic surgery settings.

Questions

AI-generated answers, 6 Oct 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 MATRIX 101 NEGATIVE GALVANIC GENERATOR used for?

    The MATRIX 101 NEGATIVE GALVANIC GENERATOR functions as an electrosurgical cutting and coagulation accessory intended for use in general and plastic surgery procedures, as defined by its classification name and product code GEI.

  • Is the MATRIX 101 NEGATIVE GALVANIC GENERATOR reusable or single-use?

    The device is supplied as a reusable device, meaning it is designed for multiple uses after appropriate cleaning and sterilization between procedures, as indicated in its FDA 510(k) submission details.

  • What regulatory clearance does the MATRIX 101 NEGATIVE GALVANIC GENERATOR have?

    The MATRIX 101 NEGATIVE GALVANIC GENERATOR received FDA 510(k) clearance under number K844816 on April 4, 1985, following a traditional review process, and was found substantially equivalent to a predicate device.