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Envision Arthroscopy System

by Envision Surgical System, Inc. 510(k)

Active United States

510(k) K942081

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942081 Date9 Nov 1994ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Envision Arthroscopy System is a medical device used for arthroscopic procedures. It is designed to provide visualization during arthroscopic surgeries, allowing surgeons to view internal structures of joints.

The system is manufactured by Envision Surgical System, Inc. and received FDA 510(k) clearance on November 9, 1994. It is authorized for use in orthopedic procedures and is distributed by the manufacturer.

Other devices from Envision Surgical System, Inc.

Questions

AI-generated answers, 24 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 Envision Arthroscopy System used for?

    The Envision Arthroscopy System is a medical device designed to provide visualization during arthroscopic procedures, allowing surgeons to view internal structures of joints during orthopedic surgeries.

  • How is the Envision Arthroscopy System supplied?

    The system is manufactured by Envision Surgical System, Inc. and distributed directly by the manufacturer. It is supplied as a complete system for arthroscopic visualization purposes.

  • What is the regulatory status of the Envision Arthroscopy System?

    The Envision Arthroscopy System received FDA 510(k) clearance on November 9, 1994, with decision code SESE indicating it was found substantially equivalent to other marketed devices.

  • Can the Envision Arthroscopy System be reused or is it single-use?

    The device data does not specify whether the Envision Arthroscopy System is designed for single-use or multiple uses. This information would be detailed in the product's instructions for use provided by the manufacturer.