Skip to content

400180

by Intuitive Surgical, Inc.

Ref 400180

400180 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 28 Aug 2026 (Basic UDI-DI 08868741200577K) and listed in FDA GUDID since 8 Jul 2016 (UDI-DI 00886874111048), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741200577K Basic UDI-DI 00886874111048UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874111048 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741200577K registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874111048 listed 8 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874111048
  2. Registered EUDAMED 08868741200577K

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  • Withdrawn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
Tip Cover Accessory
Generic name
Electrosurgical system monitor/shield
Device name
Tip cover accessory & Instrument Sheaths
Model / reference
400180
Primary DI / UDI-DI
00886874111048
Basic UDI-DI
08868741200577K
FDA product code
NAY
EMDN code
K020180 Single- and bipolar devices, single use - accessories
GMDN term
Electrosurgical system monitor/shield
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Outer 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: Electrosurgical system monitor/shield

Similar devices in this category

Other devices filed under SINGLE- AND BIPOLAR DEVICES, SINGLE USE - ACCESSORIES.

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)