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Symmetry Olsen 20003

by Aspen Surgical Products, Inc.

Part of a family of 12 devices: see the family page

Ref 20003

Symmetry Olsen 20003 is a device classified as Class I in the EU and Class II in the US made by Aspen Surgical Products, Inc., registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 0887482MonoCableLR), cleared under FDA 510(k) K111262 on 23 May 2012 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 00841785102141), active as of 25 Oct 2026. 2 FDA recalls are linked to it.

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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111262

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 Number0887482MonoCableLR Basic UDI-DI 00841785102141UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841785102141 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK111262 Date23 May 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0887482MonoCableLR registered 15 Jul 2026 Active
  • FDA 510(k) K111262 decided 23 May 2012 Active
  • FDA GUDID UDI-DI 00841785102141 listed 7 Sep 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1942-2018 FDA Class II initiated 11 May 2018
    • Terminated Z-1943-2018 FDA Class II initiated 11 May 2018

    Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Timeline

5 dated events

  1. Cleared FDA 510(k) K111262
  2. Listed FDA GUDID 00841785102141
  3. Recall initiated FDA recalls Z-1942-2018
  4. Recall initiated FDA recalls Z-1943-2018
  5. Registered EUDAMED 0887482MonoCableLR

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  • Withdrawn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
Olsen® EUDAMED
Symmetry Olsen GUDID
Generic name
Electrical-only medical device connection cable, reusable
Device name
Olsen Electrosurgical Monopolar Cable
Model / Ref / Catalog
20003
Primary DI / UDI-DI
00841785102141
Basic UDI-DI
0887482MonoCableLR
Direct marketing DI
00841785102141
510(k) Number
FDA product code
GEI
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
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: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K111262)

and 8 more cleared under K111262

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

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