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MOVIVA Hybrid Ablation Probe

by Erbe Elektromedizin GmbH

510(k) K253915Ref 20150-120

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

CE MDR 510(k)

Valid until

Not listed

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) K253915↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4050147MOVIVA-TV Basic UDI-DI 04050147023826UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147023826 UDI-DI Date1 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253915 Date18 Dec 2025ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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 · 510(k) · GUDID

Trade Name
Moviva® EUDAMED
Erbe GUDID
Generic Name
Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
Model / Ref / Catalog
20150-120
Primary DI / UDI-DI
04050147023826
Basic UDI-DI
4050147MOVIVA-TV
Direct Marketing DI
04050147023826
510(k) Number
FDA Product Code
GEI, FQH
EMDN Code
K02040199 Argon gas surgery instruments, single-use- other
GMDN Term
Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 878.4400 510(k)GUDID
880.5475 GUDID
EU market of registration
Germany
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Size
Length — 1.9 Meter

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Moviva Hybrid Ablation Probe is a hybrid endoscopic device designed for gastric mucosal ablation (GMA). It integrates high-pressure, needle-free fluid injection with argon plasma coagulation (APC) to create a protective submucosal fluid cushion while delivering superficial thermal ablation, ensuring broad and consistent tissue treatment.

This device is supplied as a reusable instrument, validated for sterilisation per ISO 11135 standards. It is intended for use in endoscopic bariatric procedures and has received FDA 510(k) clearance under the General, Plastic Surgery advisory committee (K253915). The probe is non-magnetic and suitable for MRI environments, though specific MRI safety testing should be confirmed prior to use.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What makes the Moviva Hybrid Ablation Probe different from traditional ablation methods in endoscopic bariatric procedures?

    The Moviva Hybrid Ablation Probe combines high-pressure, needle-free fluid injection with argon plasma coagulation (APC) to create a protective submucosal fluid cushion. This dual-action approach ensures broader and more consistent tissue treatment by delivering superficial thermal ablation while maintaining a stable fluid barrier, reducing the risk of complications like perforation or uneven ablation.

  • Is the Moviva Hybrid Ablation Probe single-use or reusable, and how is it sterilized?

    The Moviva Hybrid Ablation Probe is designed as a reusable instrument. It is validated for sterilization following the ISO 11135 standard, which outlines the requirements for ethylene oxide sterilization—ensuring it can be safely reused after proper sterilization procedures.

  • Can this device be used in an MRI environment, and what precautions should be taken?

    Yes, the Moviva Hybrid Ablation Probe is non-magnetic and suitable for MRI environments. However, it is recommended to confirm specific MRI safety testing with your facility’s MRI safety protocols prior to use, as individual MRI systems may have unique compatibility requirements.

  • What types of endoscopic bariatric procedures is this probe intended for?

    While the Moviva Hybrid Ablation Probe is intended for use in endoscopic bariatric procedures (as reflected in its regulatory filing under the General, Plastic Surgery advisory committee), it is specifically designed for gastric mucosal ablation (GMA). This includes procedures like endoscopic sleeve gastroplasty (ESG) or other volume-reduction techniques where controlled tissue ablation is required.

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Endocrine Disruptor
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No