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Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled Suction

by Conmed Corporation

510(k) K052104

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K052104↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK052104 Date21 Oct 2005ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

1 recall · FDA

    • Terminated Z-0165-2010 FDA Unclassified (pre-2012) initiated 30 Sep 2009

    One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GEI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Ultraclean Handcontrolled Suction Coagulator and Ultraclean Footcontrolled Suction are electrosurgical devices designed for suction and coagulation during surgical procedures. These devices combine suction and bipolar coagulation functions to assist in tissue management, haemostasis, and irrigation within the operating room.

The handcontrolled and footcontrolled models are intended for single-use applications in surgical settings. They are regulated under FDA 510(k) clearance and comply with the Medical Device Directive (MDD). Each model is supplied sterile and requires no additional preparation beyond standard surgical instrument handling, with models 130182–130185 featuring hand activation and the footcontrolled variant operated via pedal.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these devices reusable or intended for single-use only, and how does that affect their handling in the operating room?

    The Ultraclean Handcontrolled Suction Coagulator (models 130182–130185) and the Footcontrolled Suction are explicitly designed for single-use applications. This means they are pre-sterilized by the manufacturer and should not be reprocessed or reused. Clinicians should follow standard single-use surgical instrument protocols, including proper disposal after use to avoid contamination risks.

  • What are the key differences between the handcontrolled and footcontrolled models, and which one might be better suited for a specific surgical procedure?

    The handcontrolled models (130182–130185) require manual activation via a handheld trigger, offering direct control for precise suction and coagulation during procedures. The footcontrolled variant uses a pedal for activation, freeing the surgeon’s hands for other tasks. The choice depends on workflow needs—handcontrolled may suit procedures requiring constant manual adjustments, while footcontrolled could improve efficiency in longer surgeries where hand fatigue is a concern.

  • Do these devices require any special preparation before use, or can they be used immediately after opening the packaging?

    No additional preparation is required beyond standard surgical instrument handling. The devices are supplied sterile and ready for immediate use, as stated in the manufacturer’s instructions. Simply open the packaging under sterile conditions and attach the device to the electrosurgical unit following the provided guidelines.

  • What are the primary clinical functions of these devices, and how do they benefit surgical procedures?

    These devices combine suction and bipolar coagulation to assist in tissue management, hemorrhage control (hemostasis), and irrigation during surgery. Suction removes fluids and debris, while coagulation seals small blood vessels, reducing bleeding and improving visibility. This dual functionality streamlines procedures like plastic surgery, where precise tissue handling is critical.

  • How should these devices be stored to maintain their sterility and functionality before use?

    Store the devices in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed to preserve sterility, so avoid opening it prematurely. If the packaging is damaged, do not use the device—replace it with a new, intact sterile unit.