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Midas Rex PA315

by Medtronic Powered Surgical Solutions

Ref PA315

Midas Rex PA315 is a Class I device made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI 0763000B00001577G), cleared under FDA 510(k) K020069 on 18 Mar 2002 and listed in FDA GUDID since 2 Oct 2020 (UDI-DI 20763000374857), active as of 7 Nov 2026.

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

None ongoing

9 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K020069

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 Number0763000B00001577G Basic UDI-DI 20763000374857UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20763000374857 UDI-DI Date2 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK020069 Date18 Mar 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001577G registered 14 Sep 2026 Active
  • FDA 510(k) K020069 decided 18 Mar 2002 Active
  • FDA GUDID UDI-DI 20763000374857 listed 2 Oct 2020 Listed

Recalls

9 recalls · FDA

    • Terminated Z-1602-2016 FDA Class II initiated 8 Apr 2016 on shared 510(k) K020069

    Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

    • Terminated Z-0321-2016 FDA Class II initiated 21 Oct 2015 on shared 510(k) K020069

    The wire pass hole is not present on the tools.

    • Terminated Z-0546-2010 FDA Unclassified (pre-2012) initiated 30 Nov 2009 on shared 510(k) K020069

    Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.

    • Terminated Z-2156-2008 FDA Unclassified (pre-2012) initiated 30 May 2008 on shared 510(k) K020069

    Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.

    • Terminated Z-1574-05 FDA Unclassified (pre-2012) initiated 1 Sep 2005 on shared 510(k) K020069

    Potential compromise of sterile packaging for disposable dissecting tools.

    • Terminated Z-1067-05 FDA Unclassified (pre-2012) initiated 29 Jun 2005 on shared 510(k) K020069

    Complaints of finger control component breaking off and falling into open surgical wound.

    • Terminated Z-0278-05 FDA Unclassified (pre-2012) initiated 11 Nov 2004 on shared 510(k) K020069

    Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported.

    • Terminated Z-0213-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004 on shared 510(k) K020069

    Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).

    • Terminated Z-0419-03 FDA Unclassified (pre-2012) initiated 11 Nov 2002 on shared 510(k) K020069

    Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.

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

Timeline

12 dated events

  1. Recall initiated FDA recalls Z-0213-05
  2. Recall initiated FDA recalls Z-0278-05
  3. Recall initiated FDA recalls Z-1067-05
  4. Recall initiated FDA recalls Z-1574-05
  5. Recall initiated FDA recalls Z-2156-2008
  6. Recall initiated FDA recalls Z-0546-2010
  7. Recall initiated FDA recalls Z-0321-2016
  8. Recall initiated FDA recalls Z-1602-2016
  9. Listed FDA GUDID 20763000374857
  10. Registered EUDAMED 0763000B00001577G

2 earlier events are in the sections above.

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
Generic name
Surgical instrument/endoscope cleaning utensil, reusable
Device name
Accy PA300 Legend Small Cleaning Brush
Model / reference
PA315
Primary DI / UDI-DI
20763000374857
Basic UDI-DI
0763000B00001577G
Unit of use DI
00763000374853
510(k) Number
FDA product code
GEE
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Surgical instrument/endoscope cleaning utensil, reusable
Device class
Class I
Regulation number
878.4800
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
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 20763000374857: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Surgical instrument/endoscope cleaning utensil, reusable

Cleared under the same submission (K020069)

and 8 more cleared under K020069

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - OTHER.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)