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Medevice V-80 Vacuum Pump

by Berkeley Medevices

510(k) K840952

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840952 Date30 Mar 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HHI
Device Class
Class II
Regulation
21 CFR Part 884.5070
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Medevice V-80 Vacuum Pump is a Class II medical device classified under the FDA’s regulation 884.5070 as a System, Abortion, Vacuum. Designed for obstetric and gynecological procedures, this device generates controlled vacuum suction to assist in uterine evacuation during surgical abortions or other indications within its approved scope.

Supplied as a reusable medical instrument, the V-80 is intended for use in clinical settings under sterile conditions. It operates within the parameters of FDA’s 510(k) clearance (K840952), granted as substantially equivalent to a predicate device in 1984. The device adheres to regulatory standards for obstetrics/gynecology applications and is listed under product code HHI. No MRI safety or single-use specifications are noted in the available data.

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