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Medco Aspirator IV

by Medco Mfg.

510(k) K982371

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 · Abbreviated NumberK982371 Date12 Feb 1999ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The Medco Aspirator IV is a portable aspiration pump device, classified as a Pump, Portable, Aspiration (Manual Or Powered) under FDA device classification. It utilizes dual-headed positive displacement pumps designed to relieve back pressure and maintain deep vacuum for fluid aspiration, with redundancy allowing continued operation if one pump fails.

It is supplied as a reusable, non-sterile device intended for use in general and plastic surgery settings. The device operates without MRI safety specifications provided in the data, and its authorization is based on FDA 510(k) clearance (K982371) under regulation number 878.4780, with no claims of sterility, single-use status, or specific storage conditions stated in the source.

Questions

AI-generated answers, 6 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 Medco Aspirator IV used for?

    The Medco Aspirator IV is a portable aspiration pump designed for fluid aspiration in general and plastic surgery settings, utilizing dual-headed positive displacement pumps to maintain deep vacuum and relieve back pressure during procedures.

  • Is the Medco Aspirator IV sterile or single-use?

    The Medco Aspirator IV is supplied as a reusable, non-sterile device, meaning it is intended for multiple uses after appropriate cleaning and does not arrive sterile or as a single-use product.

  • How does the Medco Aspirator IV ensure continued operation during use?

    The device features dual-headed positive displacement pumps that provide redundancy; if one pump fails, the other can continue operation, ensuring sustained vacuum and aspiration capability without interruption.

  • What regulatory pathway was used for the Medco Aspirator IV?

    The Medco Aspirator IV received FDA 510(k) clearance (K982371) as substantially equivalent to a predicate device, based on an abbreviated review process under regulation number 878.4780 for portable aspiration pumps.