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SureForm 480545

by Intuitive Surgical, Inc.

Ref 480545

SureForm 480545 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 088687412095892) and listed in FDA GUDID since 21 Dec 2019 (UDI-DI 00886874117590), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number088687412095892 Basic UDI-DI 00886874117590UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874117590 UDI-DI Date21 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 088687412095892 registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874117590 listed 21 Dec 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874117590
  2. Registered EUDAMED 088687412095892

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  • Withdrawn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
SureForm Stapler 45 Curved-Tip EUDAMED
SureForm GUDID
Generic name
Robotic surgical cutting stapler, single-use
Device name
SureForm Stapler Instrument
Model / reference
480545
Primary DI / UDI-DI
00886874117590
Basic UDI-DI
088687412095892
FDA product code
GDW, NAY
EMDN code
H020301050299 Single patient articulated linear staplers without blade for videosurgery – other
GMDN term
Robotic surgical cutting stapler, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4750, 876.1500
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 14 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
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 00886874117590: EUDAMED states Yes, FDA GUDID states No.

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: Robotic surgical cutting stapler, single-use

Similar devices

Also classified as Robotic surgical cutting stapler, single-use.

Similar devices in this category

Other devices filed under SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY – OTHER.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • 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)