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Control handle P-1301

by Dex Surgical

Ref P-1301

Control handle P-1301 is a device classified as Class IIb in the EU and Class II in the US made by Dex Surgical, registered in EUDAMED on 3 Dec 2025 (Basic UDI-DI 3665772E1301P130102JM), cleared under FDA 510(k) K191878 on 29 Jan 2021 and listed in FDA GUDID since 6 May 2022 (UDI-DI 03665772000015), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191878

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3665772E1301P130102JM Basic UDI-DI 03665772000015UDI-DIDate3 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03665772000015 UDI-DI Date6 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191878 Date29 Jan 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3665772E1301P130102JM registered 3 Dec 2025 Active
  • FDA 510(k) K191878 decided 29 Jan 2021 Active
  • FDA GUDID UDI-DI 03665772000015 listed 6 May 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191878
  2. Listed FDA GUDID 03665772000015
  3. Registered EUDAMED 3665772E1301P130102JM

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  • Withdrawn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
Control handle right EUDAMED
Control handle GUDID
Generic name
Endoscopic electromechanical surgical system
Device name
Console/handle set for minimally invasive surgery
Model / reference
P-1301
Primary DI / UDI-DI
03665772000015
Basic UDI-DI
3665772E1301P130102JM
Direct marketing DI
03665772000015
510(k) Number
FDA product code
GEI
EMDN code
L1299 Laparoscopic and thoracoscopic instruments, reusable - other
GMDN term
Endoscopic electromechanical surgical system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
France
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Endoscopic electromechanical surgical system

Cleared under the same submission (K191878)

and 5 more cleared under K191878

Similar devices in this category

Other devices filed under LAPAROSCOPIC AND THORACOSCOPIC INSTRUMENTS, REUSABLE - OTHER.

Other devices from Dex Surgical

See all devices from Dex Surgical →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)