Skip to content

Riwo Drive Generator

by Richard Wolf Medical Instruments Corp.

510(k) K984304

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK984304 Date12 Aug 1999ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0790-2016 FDA Class II initiated 25 Nov 2015
    • Terminated Z-0791-2016 FDA Class II initiated 25 Nov 2015
    • Terminated Z-0789-2016 FDA Class II initiated 25 Nov 2015

    Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Richard Wolf Medical Instruments Corp.

See all devices from Richard Wolf Medical Instruments Corp. →