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470398

by Intuitive Surgical, Inc.

Ref 470398

470398 is a device classified as Class IIa in the EU and Class II in the US made by Intuitive Surgical, Inc., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 088687412103076) and listed in FDA GUDID since 8 Jul 2016 (UDI-DI 00886874112656), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number088687412103076 Basic UDI-DI 00886874112656UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874112656 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 088687412103076 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 00886874112656 listed 8 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874112656
  2. Registered EUDAMED 088687412103076

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  • Withdrawn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 Hasson Cone
Generic name
Laparoscopic access cannula, reusable
Device name
Cannulas and Reducers
Model / reference
470398
Primary DI / UDI-DI
00886874112656
Basic UDI-DI
088687412103076
Direct marketing DI
00886874112656
FDA product code
GCJ
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 registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation 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

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: Laparoscopic access cannula, reusable

Similar devices in this category

Other devices filed under ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)