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None 470064

by Intuitive Surgical, Inc.

Ref 470064

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

6 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741201016V Basic UDI-DI 00886874122099UDI-DIDate4 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874122099 UDI-DI Date23 Mar 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

6 recalls · 6 ongoing · FDA

    • Ongoing Z-2310-2026 FDA Class II initiated 24 Apr 2026

    Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

    • Ongoing Z-1355-2026 FDA Class II initiated 30 Dec 2025

    Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.

    • Ongoing Z-1428-2026 FDA Class II initiated 17 Nov 2025

    An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

    • Ongoing Z-1232-2026 FDA Class II initiated 7 Nov 2025

    Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction

    • Ongoing Z-1325-2025 FDA Class II initiated 26 Feb 2025

    Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

    • Ongoing Z-0964-2026 FDA Class II initiated 21 Aug 2024

    Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
8 mm Hex Cannula, Long EUDAMED
None GUDID
Generic Name
Laparoscopic access cannula, reusable
Device Name
Cannulas and Reducers
Model / Reference
470064
Primary DI / UDI-DI
00886874122099
Basic UDI-DI
08868741201016V
Direct Marketing DI
00886874122099
FDA Product Code
NAY
EMDN Code
L1399 Robotic surgery instruments, reusable - other
GMDN Term
Laparoscopic access cannula, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Lumen/Inner Diameter — 8 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Laparoscopic access cannula, reusable

Cleared under the same submission (K232610)

Show all (12)

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No