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ReliaTack RELTACK4XDPT

by Covidien LP

Ref RELTACK4XDPT

ReliaTack RELTACK4XDPT is a device classified as Class III in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-10884521202429), cleared under FDA 510(k) K151659 on 17 Jul 2015 and listed in FDA GUDID since 3 Aug 2017 (UDI-DI 10884521202429), active as of 24 Oct 2026.

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

CE MDD 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) K151659

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/MDD EUDAMED NumberB-10884521202429 Basic UDI-DI 10884521202429UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521202429 UDI-DI Date3 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK151659 Date17 Jul 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10884521202429 registered 30 Sep 2026 Active
  • FDA 510(k) K151659 decided 17 Jul 2015 Active
  • FDA GUDID UDI-DI 10884521202429 listed 3 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151659
  2. Listed FDA GUDID 10884521202429
  3. Registered EUDAMED B-10884521202429

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ReliaTackTM EUDAMED
ReliaTack GUDID
Generic name
Endoscopic manual linear stapler
Device name
ReliaTack™
Model / reference
RELTACK4XDPT
Primary DI / UDI-DI
10884521202429
Basic UDI-DI
B-10884521202429
510(k) Number
FDA product code
GDW
EMDN code
H020201020202 Single patient articulated linear staplers without blade for open surgery
GMDN term
Endoscopic manual linear stapler
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.4750
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Endoscopic manual linear stapler

Cleared under the same submission (K151659)

Similar devices in this category

Other devices filed under LINEAR STAPLERS, OPEN SURGERY.

Other devices from Covidien LP

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    Class II

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Properties

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