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Bei Medical Systems Smoke Evacuator

by Bei Medical Systems Co., Inc.

510(k) K940266

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 NumberK940266 Date24 Mar 1994ClearedStatusActive

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  • Withdrawn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
FYD
Device Class
Class II
Regulation
21 CFR Part 878.5070
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 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 apparatus for exhausting surgical smoke, classified under product code FYD and regulation number 878.5070. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The Bei Medical Systems Smoke Evacuator received FDA 510(k) clearance K940266 on March 24, 1994, for use in general and plastic surgery settings. It is manufactured by Bei Medical Systems Co., Inc. and is not indicated for single-use or reusable status, sterility, MRI safety, sizes, or storage conditions in the provided data.

Other devices from Bei Medical Systems Co., Inc.

Questions

AI-generated answers, 22 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 Bei Medical Systems Smoke Evacuator used for?

    The device is an apparatus for exhausting surgical smoke, intended for use in general and plastic surgery settings as indicated in its FDA 510(k) clearance.

  • How was the Bei Medical Systems Smoke Evacuator cleared for market?

    It received FDA 510(k) clearance K940266 on March 24, 1994, through the traditional pathway as a substantially equivalent device under product code FYD and regulation 878.5070.

  • Is the Bei Medical Systems Smoke Evacuator sterile or single-use?

    The provided data does not indicate whether the device is sterile, single-use, or reusable; no specifications regarding sterility or reuse status are included in the authorization details.