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Midas Rex Legend IRD400

by Medtronic Powered Surgical Solutions

Ref IRD400

Midas Rex Legend IRD400 is a device classified as Class IIa in the EU and Class II in the US made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 18 Sep 2026 (Basic UDI-DI 0763000B000203177), cleared under FDA 510(k) K081475 on 17 Oct 2008 and listed in FDA GUDID since 25 Jul 2025 (UDI-DI 20763000722351), active as of 7 Nov 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K081475

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000203177 Basic UDI-DI 20763000722351UDI-DIDate18 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20763000722351 UDI-DI Date25 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK081475 Date17 Oct 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000203177 registered 18 Sep 2026 Active
  • FDA 510(k) K081475 decided 17 Oct 2008 Active
  • FDA GUDID UDI-DI 20763000722351 listed 25 Jul 2025 Listed

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.

Timeline

6 dated events

  1. Cleared FDA 510(k) K081475
  2. Recall initiated FDA recalls Z-2085-2016
  3. Recall initiated FDA recalls Z-0158-2022
  4. Recall initiated FDA recalls Z-0961-2022
  5. Listed FDA GUDID 20763000722351
  6. Registered EUDAMED 0763000B000203177

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Midas Rex Legend
Generic name
Surgical irrigation tubing set, single-use
Device name
Irrigation Tubing
Model / reference
IRD400
Primary DI / UDI-DI
20763000722351
Basic UDI-DI
0763000B000203177
Unit of use DI
00763000722357
510(k) Number
FDA product code
HBC, HBE, HWE, HRX
EMDN code
Z12100985 Instruments for motorised neurosurgery systems - consumables
GMDN term
Surgical irrigation tubing set, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4360, 882.4310, 878.4820, 888.1100
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical irrigation tubing set, single-use

Cleared under the same submission (K081475)

and 8 more cleared under K081475

Similar devices in this category

Other devices filed under INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)