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480275

by Intuitive Surgical, Inc.

Ref 480275

480275 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 0886874119990AJ) and listed in FDA GUDID since 8 Jul 2016 (UDI-DI 00886874112731), 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 Number0886874119990AJ Basic UDI-DI 00886874112731UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874112731 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0886874119990AJ registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00886874112731 listed 8 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874112731
  2. Registered EUDAMED 0886874119990AJ

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  • Withdrawn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
Harmonic ACE Curved Shears
Generic name
Soft-tissue ultrasonic robotic surgical instrument, single-use
Device name
Ultrasonic Surgical Instrument
Model / reference
480275
Primary DI / UDI-DI
00886874112731
Basic UDI-DI
0886874119990AJ
FDA product code
NAY
EMDN code
K02020199 Ultrasonic surgery instruments, single-use - other
GMDN term
Soft-tissue ultrasonic robotic surgical instrument, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 8 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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.

Related devices

Category: Soft-tissue ultrasonic robotic surgical instrument, single-use

Similar devices in this category

Other devices filed under ULTRASONIC SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)