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Midas Rex PC700

by Medtronic Powered Surgical Solutions

Ref PC700

Midas Rex PC700 is a surgical power tool system control unit (EU MDR Class I; FDA Class I) made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 0763000B00001587J), cleared under FDA 510(k) K183515 on 12 May 2019 and listed in FDA GUDID since 4 Jul 2021 (UDI-DI 00763000337575), active as of 25 Oct 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 found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183515

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00001587J Basic UDI-DI 00763000337575UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000337575 UDI-DI Date4 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183515 Date12 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001587J registered 25 Sep 2026 Active
  • FDA 510(k) K183515 decided 12 May 2019 Active
  • FDA GUDID UDI-DI 00763000337575 listed 4 Jul 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183515
  2. Listed FDA GUDID 00763000337575
  3. Registered EUDAMED 0763000B00001587J

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  • Withdrawn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 power tool system control unit, pneumatic
Device name
Accy PC100 Legend Pneumatic Control Unit
Model / reference
PC700
Primary DI / UDI-DI
00763000337575
Basic UDI-DI
0763000B00001587J
510(k) Number
FDA product code
HSZ, HBE
EMDN code
S010499 Sterilisation containers - other
GMDN term
Surgical power tool system control unit, pneumatic
Device class
Class I
Regulation number
878.4820, 882.4310
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical power tool system control unit, pneumatic

Cleared under the same submission (K183515)

and 8 more cleared under K183515

Similar devices in this category

Other devices filed under CONTAINERS FOR STERILISATION.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)