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EndoWrist 470381

by Intuitive Surgical, Inc.

Ref 470381

EndoWrist 470381 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 27 Oct 2026 (Basic UDI-DI 08868741200647G) and listed in FDA GUDID since 8 Jul 2016 (UDI-DI 00886874112588), 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 Number08868741200647G Basic UDI-DI 00886874112588UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874112588 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741200647G registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00886874112588 listed 8 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874112588
  2. Registered EUDAMED 08868741200647G

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  • Withdrawn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
12 - 8 mm Reducer EUDAMED
EndoWrist GUDID
Generic name
Laparoscopic access cannula seal reducer, single-use
Device name
Cannulas and Reducers
Model / reference
470381
Primary DI / UDI-DI
00886874112588
Basic UDI-DI
08868741200647G
FDA product code
NAY
EMDN code
K01010180 Trocar, single-use - accessories
GMDN term
Laparoscopic access cannula seal reducer, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 14 Millimeter
Lumen/Inner Diameter — 8 Millimeter
Lumen/Inner Diameter — 12 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 seal reducer, single-use

Similar devices in this category

Other devices filed under TROCAR, SINGLE-USE.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)