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Medtronic 9733449

by Medtronic Navigation Inc.

Ref 9733449

Medtronic 9733449 is a device classified as Class I in the EU and Class II in the US made by Medtronic Navigation Inc., registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI 0763000B00027828T), cleared under FDA 510(k) K153555 on 7 Apr 2016 and listed in FDA GUDID since 11 Jun 2026 (UDI-DI 00763000811082), active as of 8 Nov 2026. 8 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

None ongoing

8 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153555

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00027828T Basic UDI-DI 00763000811082UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000811082 UDI-DI Date11 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153555 Date7 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00027828T registered 10 Jul 2026 Active
  • FDA 510(k) K153555 decided 7 Apr 2016 Active
  • FDA GUDID UDI-DI 00763000811082 listed 11 Jun 2026 Listed

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-3053-2017 FDA Class II initiated 29 Jun 2017
    • Terminated Z-3054-2017 FDA Class II initiated 29 Jun 2017
    • Terminated Z-3055-2017 FDA Class II initiated 29 Jun 2017
    • Terminated Z-3056-2017 FDA Class II initiated 29 Jun 2017
    • Terminated Z-3052-2017 FDA Class II initiated 29 Jun 2017
    • Terminated Z-3051-2017 FDA Class II initiated 29 Jun 2017
    • Terminated Z-3057-2017 FDA Class II initiated 29 Jun 2017
    • Terminated Z-3058-2017 FDA Class II initiated 29 Jun 2017

    The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.

Timeline

11 dated events

  1. Recall initiated FDA recalls Z-3053-2017
  2. Recall initiated FDA recalls Z-3054-2017
  3. Recall initiated FDA recalls Z-3055-2017
  4. Recall initiated FDA recalls Z-3056-2017
  5. Recall initiated FDA recalls Z-3052-2017
  6. Recall initiated FDA recalls Z-3051-2017
  7. Recall initiated FDA recalls Z-3057-2017
  8. Recall initiated FDA recalls Z-3058-2017
  9. Listed FDA GUDID 00763000811082
  10. Registered EUDAMED 0763000B00027828T

1 earlier event 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
Medtronic
Generic name
Multi-purpose stereotactic surgery system
Device name
EM ENT Suction
Model / reference
9733449
Primary DI / UDI-DI
00763000811082
Basic UDI-DI
0763000B00027828T
510(k) Number
FDA product code
HBB, HBC, PGW, ERL
EMDN code
Z12140580 Stereotactic ENT surgery instruments - hardware accessories
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4370, 882.4360, 882.4560, 874.4250
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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

Cleared under the same submission (K153555)

and 8 more cleared under K153555

Similar devices in this category

Other devices filed under ENT INSTRUMENTS.

Other devices from Medtronic Navigation Inc.

See all devices from Medtronic Navigation Inc. →

Properties

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