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Bovie ESRE

by Aspen Surgical Products, Inc.

Ref ESRE

Bovie ESRE is a device classified as Class IIb in the EU and Class II in the US made by Aspen Surgical Products, Inc., registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 08401132ReturnElectDispAP), cleared under FDA 510(k) K092761 on 24 Nov 2009 and listed in FDA GUDID since 28 Aug 2024 (UDI-DI 00840113237753), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K092761

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08401132ReturnElectDispAP Basic UDI-DI 00840113237753UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840113237753 UDI-DI Date28 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK092761 Date24 Nov 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08401132ReturnElectDispAP registered 5 Oct 2026 Active
  • FDA 510(k) K092761 decided 24 Nov 2009 Active
  • FDA GUDID UDI-DI 00840113237753 listed 28 Aug 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K092761
  2. Listed FDA GUDID 00840113237753
  3. Registered EUDAMED 08401132ReturnElectDispAP

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  • Withdrawn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
Bovie® EUDAMED
Bovie GUDID
Generic name
Electrosurgical return electrode, single-use
Open-surgery electrosurgical electrode, monopolar, single-use
Device name
Electrosurgical Device, Return Electrode (disposable)
Model / reference
ESRE
Primary DI / UDI-DI
00840113237753, 00887482181140
Basic UDI-DI
08401132ReturnElectDispAP
510(k) Number
FDA product code
GEI
EMDN code
K02010303 High temperature bipolar electrocauters, single use
GMDN term
Electrosurgical return electrode, single-use
Open-surgery electrosurgical electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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: Electrosurgical return electrode, single-use

Cleared under the same submission (K092761)

and 7 more cleared under K092761

Similar devices in this category

Other devices filed under MONO- AND BIPOLAR DEVICES, SINGLE-USE.

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date YesGUDIDNoGUDID
  • Manufacturing date
Other properties (20, all answered No)