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AIM (Advanced Imaging Modality) 0502537030

by Stryker Corp.

Ref 0502-537-030Model 08858251004947U7

AIM (Advanced Imaging Modality) 0502537030 (0502-537-030) is a rigid optical laparoscope (EU MDR Class IIa; FDA Class II; FDA product code OWN, Confocal optical imaging) made by Stryker Corp., registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 08858251004947U7), cleared under FDA 510(k) K210088 on 13 Apr 2021 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07613327059373), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210088

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251004947U7 Basic UDI-DI 07613327059373UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210088 Date13 Apr 2021DecidedStatusActive
United StatesGUDID listing GUDID Number07613327059373 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251004947U7 registered 7 Oct 2026 Active
  • FDA 510(k) K210088 decided 13 Apr 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07613327059373 listed 23 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K142310
  2. Listed FDA GUDID 07613327059373
  3. Cleared FDA 510(k) K210088
  4. Registered EUDAMED 08858251004947U7

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  • Withdrawn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
AIM (Advanced Imaging Modality)
Generic name
Rigid optical laparoscope
Device name
ENDO_TF10562_Laparoscopes
Model / Ref / Catalog
08858251004947U7, 0502-537-030, 0502537030
Primary DI / UDI-DI
07613327059373
Basic UDI-DI
08858251004947U7
Direct marketing DI
07613327059373
510(k) Number
FDA product code
OWN
EMDN code
Z12029009 Laparoscopes
GMDN term
Rigid optical laparoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Length — 30.0 Centimeter
Outer Diameter — 5.4 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251004947U7
0502-537-030
GUDID
0502537030
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: Rigid optical laparoscope

Cleared under the same submission (K142310)

and 1 more cleared under K142310

Cleared under the same submission (K210088)

Similar devices in this category

Other devices filed under LAPAROSCOPES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)