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Mediport 2000 Mobile

by Servox Medizintechnik GmbH

510(k) K013585

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 NumberK013585 Date28 Jan 2002ClearedStatusActive

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  • Withdrawn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
BTA
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Mediport 2000 Mobile is a portable, powered suction pump designed for aspiration procedures. It is classified as a Class II medical device and is used for manual or powered aspiration in general and plastic surgery settings.

The device is supplied by Servox Medizintechnik GmbH and has received FDA 510(k) clearance with the regulation number 878.4780. It is substantially equivalent to predicate devices and is intended for use in medical environments where aspiration is required.

Questions

AI-generated answers, 27 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 is the Mediport 2000 Mobile used for?

    The Mediport 2000 Mobile is a portable, powered suction pump designed for aspiration procedures in general and plastic surgery settings. It can be used for both manual and powered aspiration in medical environments where fluid removal is required.

  • Is the Mediport 2000 Mobile a single-use or reusable device?

    The device data does not specify whether the Mediport 2000 Mobile is designed for single-use or multiple uses. As a Class II medical device intended for aspiration procedures, it would typically be designed for reuse following appropriate sterilization protocols, but specific usage instructions would be provided by the manufacturer.

  • What regulatory approvals does the Mediport 2000 Mobile have?

    The Mediport 2000 Mobile has received FDA 510(k) clearance with regulation number 878.4780. It is classified as a Class II medical device and is substantially equivalent to predicate devices, making it suitable for use in medical environments where aspiration procedures are performed.

  • How is the Mediport 2000 Mobile supplied?

    The Mediport 2000 Mobile is supplied by Servox Medizintechnik GmbH, located at 69 Servatiusstrasse, Koln, Germany with postal code 51109. The device is designed as a portable, powered suction pump for aspiration procedures in general and plastic surgery settings.