Skip to content

Emprint CA20L2

by Covidien LP

Ref CA20L2

Emprint CA20L2 is a microwave ablation system probe (EU MDR Class IIb; FDA Class II) made by Covidien LP, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI 0763000B00001006K), cleared under FDA 510(k) K163105 on 6 Dec 2016 and listed in FDA GUDID since 15 May 2020 (UDI-DI 10884521806559), active as of 25 Oct 2026. 3 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

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163105

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 Number0763000B00001006K Basic UDI-DI 10884521806559UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521806559 UDI-DI Date15 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK163105 Date6 Dec 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001006K registered 16 Oct 2026 Active
  • FDA 510(k) K163105 decided 6 Dec 2016 Active
  • FDA GUDID UDI-DI 10884521806559 listed 15 May 2020 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0626-2019 FDA Class II initiated 15 Nov 2018
    • Ongoing Z-0625-2019 FDA Class II initiated 15 Nov 2018
    • Ongoing Z-0627-2019 FDA Class II initiated 15 Nov 2018

    The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

Timeline

6 dated events

  1. Cleared FDA 510(k) K163105
  2. Recall initiated FDA recalls Z-0626-2019
  3. Recall initiated FDA recalls Z-0625-2019
  4. Recall initiated FDA recalls Z-0627-2019
  5. Listed FDA GUDID 10884521806559
  6. Registered EUDAMED 0763000B00001006K

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
Emprint™ Thermosphere™ EUDAMED
Emprint GUDID
Generic name
Microwave ablation system probe, non-powered
Device name
Emprint™ Reinforced Percutaneous Antenna
Model / reference
CA20L2
Primary DI / UDI-DI
10884521806559
Basic UDI-DI
0763000B00001006K
510(k) Number
FDA product code
NEY, GEI
EMDN code
K0299 Electrosurgery devices, single-use - other
GMDN term
Microwave ablation system probe, non-powered
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 20 Centimeter

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: Microwave ablation system probe, non-powered

Cleared under the same submission (K163105)

and 1 more cleared under K163105

Similar devices in this category

Other devices filed under ELECTROSURGERY DEVICES, SINGLE-USE - OTHER.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

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