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Aspen Surgical Systems Coated Blade Electrode

by Conmedcorp

510(k) K935091

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK935091 Date28 Feb 1994ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0452-2008 FDA Unclassified (pre-2012) initiated 2 Nov 2007

    Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal

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  • Withdrawn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, 1 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 electrode accessory, as defined by its classification name. It is a coated blade electrode designed for use in electrosurgical procedures.

It is supplied as a single-use device, with PTFE (polytetrafluoroethylene) coating to resist eschar buildup and improve tissue movement. The device received FDA 510(k) clearance K935091 on February 28, 1994, and is classified under product code GEI for general and plastic surgery applications.

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Questions

AI-generated answers, 1 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 ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE used for?

    It is an electrosurgical cutting and coagulation electrode accessory designed for use in electrosurgical procedures, specifically for general and plastic surgery applications as indicated by its product code GEI.

  • Is the ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE reusable or single-use?

    The device is supplied as a single-use device, meaning it is intended for one procedure only and should not be reprocessed or reused due to the risk of cross-contamination and coating degradation.

  • What coating does the ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE have and what is its purpose?

    The electrode features a PTFE (polytetrafluoroethylene) coating that resists eschar buildup during use and improves tissue movement, enhancing surgical efficiency and reducing the need for frequent cleaning during procedures.