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N/A EA201

by Medtronic Xomed, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000548766 UDI-DI Date3 May 2025ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0158-2022 FDA Class II initiated 31 Aug 2021

    There was an increase in complaints related to tip breaks and wobble/vibration.

    • Terminated Z-0961-2022 FDA Class II initiated 15 Dec 2021 on shared 510(k) K081475

    As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.

    • Terminated Z-2085-2016 FDA Class II initiated 13 May 2016

    Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Surgical power tool system control unit, pneumatic
Model / Reference
EA201
Primary DI / UDI-DI
00763000548766
510(k) Number
FDA Product Code
HBE
GMDN Term
Surgical power tool system control unit, pneumatic
Device Class
Class II
Regulation Number
882.4310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical power tool system control unit, pneumatic

Cleared under the same submission (K081475)

Show all (12)

Other devices from Medtronic Xomed, Inc.

See all devices from Medtronic Xomed, Inc. →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No