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400160

by Intuitive Surgical, Inc. 2 variants

Ref 400160

400160 is a device classified as Class IIb in the EU and Class II in the US made by Intuitive Surgical, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 088687412284694) and listed in FDA GUDID since 23 Sep 2025 (UDI-DI 00886874125946), 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 Number088687412284694 Basic UDI-DI 00886874125946UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874125946 UDI-DI Date23 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 088687412284694 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00886874125946 listed 23 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874125946
  2. Registered EUDAMED 088687412284694

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  • Withdrawn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
Cautery Spatula Tip, 5 mm
Generic name
Endoscopic electrosurgical electrode, monopolar, single-use
Device name
Cautery Tips
Model / reference
400160
Primary DI / UDI-DI
00886874125946
Basic UDI-DI
088687412284694
FDA product code
NAY
EMDN code
K020199 Mono- and bipolar devices, single use - other
GMDN term
Endoscopic electrosurgical electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00886874125946: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

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

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)