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Endo Bag 25030

by Covidien LP

Ref 25030

Endo Bag 25030 is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 0763000B00001897V), cleared under FDA 510(k) K913762 on 28 Oct 1991 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884523000962), 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) K913762

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 Number0763000B00001897V Basic UDI-DI 10884523000962UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884523000962 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK913762 Date28 Oct 1991DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001897V registered 5 Oct 2026 Active
  • FDA 510(k) K913762 decided 28 Oct 1991 Active
  • FDA GUDID UDI-DI 10884523000962 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K913762
  2. Listed FDA GUDID 10884523000962
  3. Registered EUDAMED 0763000B00001897V

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  • Withdrawn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
Endo BagTM AutoSutureTM EUDAMED
Endo Bag GUDID
Generic name
Tissue extraction bag
Device name
EndoBag™ Specimen Retrieval System
Model / reference
25030
Primary DI / UDI-DI
10884523000962
Basic UDI-DI
0763000B00001897V
510(k) Number
FDA product code
GCJ
EMDN code
A090101 Organ collection bags
GMDN term
Tissue extraction bag
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Height — 6 Inch
Width — 3 Inch

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: Tissue extraction bag

Cleared under the same submission (K913762)

Similar devices in this category

Other devices filed under ORGAN COLLECTION CONTAINERS.

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)