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GoldVac Smoke Evacuation Pencil 60-7570-005

by Conmed Corporation United States EUDAMED510(k)GUDID

Ref 60-7570-005510(k) K081634

Product code GEIEMDN K02030109

Overview

The GoldVac Smoke Evacuation Pencil 60-7570-005 is an active, non-orthopedic electrosurgical instrument designed for smoke evacuation during surgical procedures. Classified under nomenclature code K02030109, this device combines electrosurgical functionality with integrated smoke removal to mitigate exposure to surgical plume hazards. It is intended for use with electrosurgical units to deliver current while simultaneously evacuating smoke from the operative site.

This single-use, sterile device is supplied as a disposable pencil-style instrument, requiring no reprocessing. It is compatible with standard electrosurgical systems and is regulated under FDA 510K clearance, MDD, and MDR compliance. The device is non-implantable, non-latex, and does not contain animal or human tissues. Storage and handling follow standard sterile medical device protocols, with a unique Basic UDI (B-10653405061199) for traceability.

Summary written by AI from registry data, 20 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-10653405061199 Basic UDI-DIDate11 Apr 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-10653405061199 Basic UDI-DIDate11 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10653405061199 UDI-DIDate19 Dec 2020ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK081634 Date25 Jun 2008ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Full name
GoldVac
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device Name
Non-orthopedic, Active, Instrument, Electrosurgical, Pencil, Smoke Evacuation
Model / Ref / Catalog
60-7570-005
Primary DI / UDI-DI
10653405061199
Basic UDI-DI
B-10653405061199
FDA Product Code
GEI
EMDN Code
K02030109 Radiofrequency surgery handpieces, single-use
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Sterilization Method
Radiation Sterilization
Size
Length — 15 Feet

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

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See all devices from Conmed Corporation →

Questions

  • What is the primary purpose of the GoldVac Smoke Evacuation Pencil, and how does it differ from standard electrosurgical tools?

    The GoldVac is designed specifically to combine smoke evacuation with electrosurgical functionality, reducing exposure to surgical plume hazards during procedures. Unlike standard electrosurgical tools, it actively removes smoke from the operative site while delivering electrosurgical current, making it ideal for procedures where plume control is critical.

  • Is the GoldVac reusable, and if not, how should it be handled after use?

    No, the GoldVac is a single-use, sterile device and must not be reprocessed or reused. After use, it should be disposed of according to standard sterile medical device protocols to ensure patient safety and compliance with regulatory requirements.

  • What regulatory pathways does the GoldVac follow, and who is responsible for its distribution in Europe?

    The GoldVac is cleared under FDA 510K in the U.S. and complies with both the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in Europe. In the EU, MDSS GmbH (SRN: DE-AR-000005430) is the authorized representative responsible for its distribution.

  • How do I identify the correct model of GoldVac for my electrosurgical system?

    The GoldVac is supplied as the disposable pencil-style instrument with the reference number 60-7570-005. It is designed for compatibility with standard electrosurgical systems, so verify your system’s specifications to ensure proper integration. The device’s unique Basic UDI (B-10653405061199) also aids in traceability.

  • What storage requirements apply to the GoldVac, and does it contain any allergens?

    The GoldVac must be stored following standard sterile medical device protocols to maintain its sterility. It is non-latex and does not contain animal or human tissues, making it suitable for patients with latex sensitivities or allergies. Always check the packaging for expiration dates and storage instructions.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED fd45ba2c-ea39-4279-affe-e3d67582685c 85 fields · synced 22 Oct 2026
  • FDA UDI 6e9bb846-ca48-49ee-a700-02a305122b4d 37 fields · synced 30 May 2026
  • FDA 510(k) K081634 1 fields · synced 18 May 2026