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Signia SIGTRAY

by Covidien LP

Ref SIGTRAY

Signia SIGTRAY is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 0763000B00001076Z), cleared under FDA 510(k) K240881 on 1 Nov 2024 (2 earlier submissions) and listed in FDA GUDID since 31 Jul 2017 (UDI-DI 10884521543898), 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) K240881

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00001076Z Basic UDI-DI 10884521543898UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240881 Date1 Nov 2024DecidedStatusActive
United StatesGUDID listing GUDID Number10884521543898 UDI-DI Date31 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001076Z registered 1 Jul 2026 Active
  • FDA 510(k) K240881 decided 1 Nov 2024 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10884521543898 listed 31 Jul 2017 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K161347
  2. Listed FDA GUDID 10884521543898
  3. Cleared FDA 510(k) K201672
  4. Cleared FDA 510(k) K240881
  5. Registered EUDAMED 0763000B00001076Z

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  • Withdrawn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
Signia™ EUDAMED
Signia GUDID
Generic name
Instrument tray, reusable
Device name
Signia Stapler
Model / reference
SIGTRAY
Primary DI / UDI-DI
10884521543898
Basic UDI-DI
0763000B00001076Z
Direct marketing DI
10884521543898
510(k) Number
FDA product code
KCT
EMDN code
H020380 Staplers, videosurgery - accessories
GMDN term
Instrument tray, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Netherlands
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: Instrument tray, reusable

Cleared under the same submission (K201672)

and 5 more cleared under K201672

Cleared under the same submission (K240881)

Similar devices in this category

Other devices filed under STAPLERS FOR VIDEOSURGERY.

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Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)