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Apyx® APYX-ESREC

by Apyx Medical Corporation

Ref APYX-ESREC

Apyx® APYX-ESREC is a device classified as Class I in the EU and Class II in the US made by Apyx Medical Corporation, registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-10607151049970), cleared under FDA 510(k) K092761 on 24 Nov 2009 and listed in FDA GUDID since 13 May 2021 (UDI-DI 10607151049970), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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, self-declared

Class I: no certifier involved

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/MDD EUDAMED NumberB-10607151049970 Basic UDI-DI 10607151049970UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10607151049970 UDI-DI Date13 May 2021ListedStatusListed 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 B-10607151049970 registered 24 Jun 2026 Active
  • FDA 510(k) K092761 decided 24 Nov 2009 Active
  • FDA GUDID UDI-DI 10607151049970 listed 13 May 2021 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K092761
  2. Listed FDA GUDID 10607151049970
  3. Registered EUDAMED B-10607151049970

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Disposable Split Adult Return Electrode with Cable EUDAMED
Apyx® GUDID
Generic name
Electrosurgical return electrode, single-use
Model / Ref / Catalog
APYX-ESREC
Primary DI / UDI-DI
10607151049970
Basic UDI-DI
B-10607151049970
510(k) Number
FDA product code
GEI
EMDN code
K02010201 Electrosurgery single patient pads (neutral electrodes), single-use
GMDN term
Electrosurgical return electrode, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

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: 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 ELECTROSURGERY SINGLE PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE.

Other devices from Apyx Medical Corporation

See all devices from Apyx Medical Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)