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EEA OrVil EEAORVIL25A

by Covidien LP

Ref EEAORVIL25A

EEA OrVil EEAORVIL25A is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 0763000B00001156Y), cleared under FDA 510(k) K093402 on 12 Nov 2009 and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 10884521042872), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093402

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00001156Y Basic UDI-DI 10884521042872UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521042872 UDI-DI Date22 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK093402 Date12 Nov 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001156Y registered 26 Aug 2026 Active
  • FDA 510(k) K093402 decided 12 Nov 2009 Active
  • FDA GUDID UDI-DI 10884521042872 listed 22 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K093402
  2. Listed FDA GUDID 10884521042872
  3. Registered EUDAMED 0763000B00001156Y

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  • Withdrawn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
EEATM OrVilTM EUDAMED
EEA OrVil GUDID
Generic name
Intraluminal circular stapler, single-use
Device name
Eea™ Orvil™ Auto Suture™ Transoral Circu
Model / reference
EEAORVIL25A
Primary DI / UDI-DI
10884521042872
Basic UDI-DI
0763000B00001156Y
510(k) Number
FDA product code
GDW
EMDN code
H02030299 Circular staplers for videosurgery – other
GMDN term
Intraluminal circular stapler, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4750
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 25 Millimeter
Length — 90 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Intraluminal circular stapler, single-use

Cleared under the same submission (K093402)

Similar devices in this category

Other devices filed under STAPLERS FOR VIDEOSURGERY.

Other devices from Covidien LP

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    Class II

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  • 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)