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SureForm 436504

by Intuitive Surgical, Inc.

Ref 436504

SureForm 436504 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 19 Aug 2026 (Basic UDI-DI 08868741202247E), cleared under FDA 510(k) K243596 on 10 Mar 2025 and listed in FDA GUDID since 20 Jun 2025 (UDI-DI 00886874123652), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243596

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741202247E Basic UDI-DI 00886874123652UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874123652 UDI-DI Date20 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243596 Date10 Mar 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08868741202247E registered 19 Aug 2026 Active
  • FDA 510(k) K243596 decided 10 Mar 2025 Active
  • FDA GUDID UDI-DI 00886874123652 listed 20 Jun 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243596
  2. Listed FDA GUDID 00886874123652
  3. Registered EUDAMED 08868741202247E

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SureForm 45 Curved Tip Stapler EUDAMED
SureForm GUDID
Generic name
Robotic surgical cutting stapler, single-use
Device name
SureForm Stapler Instrument
Model / reference
436504
Primary DI / UDI-DI
00886874123652
Basic UDI-DI
08868741202247E
FDA product code
NAY, GDW
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
876.1500, 878.4750
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
Size
Length — 45 Millimeter
Outer Diameter — 14 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: Robotic surgical cutting stapler, single-use

Cleared under the same submission (K243596)

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
  • 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)