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Synaptive Long Pointer

by Synaptive Medical Inc.

Part of a family of 6 devices: see the family page

Ref SYN-0975Model SYN-0642

Synaptive Long Pointer (SYN-0975) is a device classified as Class I in the EU and Class II in the US made by Synaptive Medical Inc, registered in EUDAMED on 11 Apr 2025 (Basic UDI-DI 67008200005LR), cleared under FDA 510(k) K183325 on 14 Jul 2019 and listed in FDA GUDID since 3 Jan 2023 (UDI-DI 00670082000535), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183325

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number67008200005LR Basic UDI-DI 00670082000535UDI-DIDate11 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00670082000535 UDI-DI Date3 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183325 Date14 Jul 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 67008200005LR registered 11 Apr 2025 Active
  • FDA 510(k) K183325 decided 14 Jul 2019 Active
  • FDA GUDID UDI-DI 00670082000535 listed 3 Jan 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183325
  2. Listed FDA GUDID 00670082000535
  3. Registered EUDAMED 67008200005LR

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  • Withdrawn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
Synaptive Long Pointer EUDAMED
Long Pointer GUDID
Generic name
Neurological stereotactic surgery system
Device name
Standard Pointer
Model / reference
SYN-0642, SYN-0975
Primary DI / UDI-DI
00670082000535
Basic UDI-DI
67008200005LR
Direct marketing DI
00670082000535
510(k) Number
FDA product code
HAW
EMDN code
L031199 Probes and mirrors, reusable - other
GMDN term
Neurological stereotactic surgery system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Spain
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.

Manufacturer details

EUDAMED SRN
CA-MF-000010705
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under PROBES AND MIRRORS, REUSABLE - OTHER.

Other devices from Synaptive Medical Inc

See all devices from Synaptive Medical Inc →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)