Skip to content

Symmetry Roeder 91-0630

by Aspen Surgical Products, Inc.

Ref 91-0630

Symmetry Roeder 91-0630 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 28 Aug 2026 (Basic UDI-DI 08401132Applicator3V), cleared under FDA 510(k) K040855 on 16 Apr 2004 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00840113266005), 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) K040855

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 Number08401132Applicator3V Basic UDI-DI 00840113266005UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840113266005 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK040855 Date16 Apr 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08401132Applicator3V registered 28 Aug 2026 Active
  • FDA 510(k) K040855 decided 16 Apr 2004 Active
  • FDA GUDID UDI-DI 00840113266005 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K040855
  2. Listed FDA GUDID 00840113266005
  3. Registered EUDAMED 08401132Applicator3V

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  • Withdrawn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
Symmetry® EUDAMED
Symmetry Roeder GUDID
Generic name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device name
Applicators
Model / Ref / Catalog
91-0630
Primary DI / UDI-DI
00840113266005 EUDAMED
00887482130353 GUDID
Basic UDI-DI
08401132Applicator3V
510(k) Number
FDA product code
GEI
EMDN code
L149099 ENT instruments, reusable - other
GMDN term
Open-surgery electrosurgical handpiece/electrode, bipolar, 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
Size
Length — 6.875 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00840113266005
GUDID
00887482130353
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00840113266005; FDA GUDID lists 00887482130353), so their flags are not compared. 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: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Cleared under the same submission (K040855)

and 8 more cleared under K040855

Similar devices in this category

Other devices filed under ENT INSTRUMENTS, REUSABLE - OTHER.

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

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