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Smoke/Odor Evacuator #757

by Olsen Electrosurgical, Inc.

510(k) K912612

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 NumberK912612 Date1 Nov 1991ClearedStatusActive

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  • Withdrawn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, 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 apparatus for exhaust in surgical settings, specifically designed as a smoke/odor evacuator. It is substantially equivalent to a predicate device and cleared under FDA 510(k) K912612.

It is supplied by Olsen Electrosurgical, Inc. for use in general and plastic surgery environments. The device has product code FYD and is regulated under 21 CFR 878.5070.

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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 SMOKE/ODOR EVACUATOR #757 used for?

    This device is an apparatus for exhaust in surgical settings, specifically designed as a smoke/odor evacuator for use in general and plastic surgery environments to remove surgical smoke and odors during procedures.

  • How is the SMOKE/ODOR EVACUATOR #757 supplied and by whom?

    The device is supplied by Olsen Electrosurgical, Inc. for use in general and plastic surgery environments, as indicated in the manufacturer and device description fields.

  • What regulatory pathway was used for the SMOKE/ODOR EVACUATOR #757?

    The device was cleared under FDA 510(k) K912612 as substantially equivalent to a predicate device, with a traditional clearance type and decision date of November 1, 1991.