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Accuro Locator Needle Guide Kit 4741

by Protek Medical Products, Inc.

Ref 1-535-4741

Accuro Locator Needle Guide Kit 4741 is a device classified as Class I in the EU and Class II in the US made by Protek Medical Products, Inc., registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 084191215000STNE), cleared under FDA 510(k) K973958 on 22 Jan 1998 (1 earlier submission) and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00841912101146), 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) K973958

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084191215000STNE Basic UDI-DI 00841912101146UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841912101146 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK973958 Date22 Jan 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084191215000STNE registered 15 Jul 2026 Active
  • FDA 510(k) K973958 decided 22 Jan 1998 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841912101146 listed 16 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K970889
  2. Cleared FDA 510(k) K973958
  3. Listed FDA GUDID 00841912101146
  4. Registered EUDAMED 084191215000STNE

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  • Withdrawn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
aspen surgical® EUDAMED
Accuro Locator Needle Guide Kit GUDID
Generic name
Body-surface ultrasound imaging transducer cover
Device name
Needle Guides (sterile)
Model / Ref / Catalog
1-535-4741 EUDAMED
4741 GUDID
Primary DI / UDI-DI
00841912101146
Basic UDI-DI
084191215000STNE
510(k) Number
FDA product code
KKX, ITX
EMDN code
A018002 Needle guides
GMDN term
Body-surface ultrasound imaging transducer cover
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4370, 892.1570
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1-535-4741
GUDID
4741
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Needle guide, single-useBody-surface ultrasound imaging transducer cover

Cleared under the same submission (K970889)

and 8 more cleared under K970889

Cleared under the same submission (K973958)

and 8 more cleared under K973958

Other devices from Protek Medical Products, Inc.

See all devices from Protek Medical Products, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)