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Wiltek Electrocautery Adaptor

by Wiltek Medical, Inc.

510(k) K914131

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 NumberK914131 Date25 Sep 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  • Withdrawn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
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, 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 Wiltek Electrocautery Adaptor is a medical device designed as an attachment for electrocautery instruments. It facilitates precise tissue cutting and coagulation during surgical procedures, particularly in general and plastic surgery applications.

This device is supplied as a reusable accessory and is intended for use in sterile surgical settings. It is classified under product code GEI and has received FDA 510(k) clearance with the designation K914131, determined to be substantially equivalent to a predicate device. No specific MRI safety or sterility requirements beyond standard surgical protocols are noted in the regulatory data.

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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 Wiltek Electrocautery Adaptor primarily used for?

    The Wiltek Electrocautery Adaptor is specifically designed for general and plastic surgery applications. It attaches to electrocautery instruments to enable precise cutting and coagulation of tissue during surgical procedures in these fields.

  • Is the Wiltek Electrocautery Adaptor intended for single-use or reusable applications?

    The Wiltek Electrocautery Adaptor is supplied as a reusable accessory, meaning it is meant to be sterilized and reused in sterile surgical settings rather than discarded after a single use.

  • How is the Wiltek Electrocautery Adaptor regulated by the FDA?

    The Wiltek Electrocautery Adaptor received FDA 510(k) clearance under the designation K914131, with a decision that it is substantially equivalent to a predicate device. This clearance was granted through a traditional review process, and it is classified under product code GEI.

  • Are there any special storage requirements for the Wiltek Electrocautery Adaptor?

    The device does not specify unique storage requirements beyond standard surgical protocols. Since it is reusable and intended for sterile use, it should be stored in a clean, dry environment and sterilized before each use following established surgical protocols.