Skip to content

Accu-Beam 1109

by Transamerican Technologies International

Part of a family of 9 devices: see the family page

Ref 1109

Accu-Beam 1109 is a device classified as Class I in the EU and Class II in the US made by Transamerican Technologies International, cleared under FDA 510(k) K864378 on 5 Mar 1987, registered in EUDAMED (Basic UDI-DI ++B177015Q) and listed in FDA GUDID since 8 Jul 2016 (UDI-DI B17711090), 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) K864378

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberB17711090 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK864378 Date5 Mar 1987DecidedStatusActive
European UnionCE/MDR EUDAMED Number++B177015Q Basic UDI-DI B17711090UDI-DIDate—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K864378 decided 5 Mar 1987 Active
  • EUDAMED Basic UDI-DI ++B177015Q Active
  • FDA GUDID UDI-DI B17711090 listed 8 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K864378
  2. Listed FDA GUDID B17711090

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  • Withdrawn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
Accu-Beam Sharplan Thread Adapter EUDAMED
Accu-Beam GUDID
Generic name
Laser adaptor
Device name
Accu-Beam Laser Accessories
Model / reference
1109
Primary DI / UDI-DI
B17711090
Basic UDI-DI
++B177015Q
510(k) Number
FDA product code
HHR
EMDN code
Z12011099 Laser surgery instruments - other
GMDN term
Laser adaptor
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.4550
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

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: Laser adaptor

Cleared under the same submission (K864378)

and 8 more cleared under K864378

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - OTHER.

Other devices from Transamerican Technologies International

See all devices from Transamerican Technologies International →

Properties

Other properties (25, all answered No)