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Microspeed Uni Motor System

by Aesculap, Inc.

510(k) K053526

Microspeed Uni Motor System is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K053526 on 18 Jan 2006, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK053526 Date18 Jan 2006ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1474-2011 FDA Unclassified (pre-2012) initiated 22 Nov 2010

    Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion.

Timeline

2 dated events

  1. Cleared FDA 510(k) K053526
  2. Recall initiated FDA recalls Z-1474-2011

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  • Withdrawn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
HBC
Device class
Class II
Regulation
21 CFR Part 882.4360
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code HBC (Motor, Drill, Electric).

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