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432701

by Intuitive Surgical, Inc.

Ref 432701

432701 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 088687412294597), cleared under FDA 510(k) K243582 on 28 Feb 2025 and listed in FDA GUDID since 8 Jul 2025 (UDI-DI 00886874124598), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243582

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number088687412294597 Basic UDI-DI 00886874124598UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874124598 UDI-DI Date8 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243582 Date28 Feb 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 088687412294597 registered 19 Aug 2026 Active
  • FDA 510(k) K243582 decided 28 Feb 2025 Active
  • FDA GUDID UDI-DI 00886874124598 listed 8 Jul 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243582
  2. Listed FDA GUDID 00886874124598
  3. Registered EUDAMED 088687412294597

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  • Withdrawn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
Advanced Access Port Kit, Large Incision
Generic name
Laparoscopic multi-instrument access port, single-use
Device name
Insertion kits
Model / reference
432701
Primary DI / UDI-DI
00886874124598
Basic UDI-DI
088687412294597
FDA product code
NAY
EMDN code
K01020299 Robotic surgery instrument, single-use - other
GMDN term
Laparoscopic multi-instrument access port, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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: Laparoscopic multi-instrument access port, single-use

Similar devices in this category

Other devices filed under MINIMALLY INVASIVE AND ROBOTIC 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)