Skip to content

Scanlan® 9009-648-10

by Scanlan International Inc

Ref 9009-648-10

Scanlan® 9009-648-10 is a device classified as Class I in the EU and Class II in the US made by Scanlan International Inc, registered in EUDAMED on 18 May 2026 (Basic UDI-DI B-00846159030174), cleared under FDA 510(k) K945474 on 5 Dec 1994 and listed in FDA GUDID since 28 Jan 2016 (UDI-DI 00846159030174), active as of 23 Oct 2026.

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

CE MDD 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) K945474

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00846159030174 Basic UDI-DI 00846159030174UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846159030174 UDI-DI Date28 Jan 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK945474 Date5 Dec 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00846159030174 registered 18 May 2026 Active
  • FDA 510(k) K945474 decided 5 Dec 1994 Active
  • FDA GUDID UDI-DI 00846159030174 listed 28 Jan 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K945474
  2. Listed FDA GUDID 00846159030174
  3. Registered EUDAMED B-00846159030174

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Scanlan®
Generic name
Rigid endoscopic tissue manipulation forceps, reusable
Device name
SCANLAN® CardioVasive™ Jacobson Needle Holder
Model / Ref / Catalog
9009-648-10
Primary DI / UDI-DI
00846159030174
Basic UDI-DI
B-00846159030174
510(k) Number
FDA product code
GCJ
EMDN code
L0205 Needle holders, reusable
GMDN term
Rigid endoscopic tissue manipulation forceps, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 endoscopic tissue manipulation forceps, reusable

Cleared under the same submission (K945474)

and 8 more cleared under K945474

Similar devices in this category

Other devices filed under NEEDLE HOLDERS, REUSABLE.

Other devices from Scanlan International Inc

See all devices from Scanlan International Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)