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Cyber Blade 20041001

by Sidam SRL

Ref 20041001

Cyber Blade 20041001 is a device classified as Class IIa in the EU and Class II in the US made by Sidam SRL, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 805141496TD14B5V), cleared under FDA 510(k) K192499 on 31 Jul 2020 and listed in FDA GUDID since 4 Feb 2021 (UDI-DI 08051414960468), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192499

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805141496TD14B5V Basic UDI-DI 08051414960468UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08051414960468 UDI-DI Date4 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192499 Date31 Jul 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805141496TD14B5V registered 3 Nov 2026 Active
  • FDA 510(k) K192499 decided 31 Jul 2020 Active
  • FDA GUDID UDI-DI 08051414960468 listed 4 Feb 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192499
  2. Listed FDA GUDID 08051414960468
  3. Registered EUDAMED 805141496TD14B5V

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  • Withdrawn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
Cyber Blade Tool Body EUDAMED
Cyber Blade GUDID
Generic name
Tissue morcellation system handpiece, battery-powered
Device name
Morcellator and accessory device for morcellation of prostatic tissue in urology
Model / reference
20041001
Primary DI / UDI-DI
08051414960468
Basic UDI-DI
805141496TD14B5V
510(k) Number
FDA product code
GCJ
EMDN code
Z12080204 Morcellators
GMDN term
Tissue morcellation system handpiece, battery-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
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 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: Tissue morcellation system handpiece, battery-powered

Cleared under the same submission (K192499)

Similar devices in this category

Other devices filed under MORCELLATORS.

Other devices from Sidam SRL

Properties

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