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ReliaTack RELTACK5R

by Covidien LP

Ref RELTACK5R

ReliaTack RELTACK5R 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-20884521202419), cleared under FDA 510(k) K140609 on 9 Apr 2014 and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 20884521202419), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140609

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/MDD EUDAMED NumberB-20884521202419 Basic UDI-DI 20884521202419UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20884521202419 UDI-DI Date22 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK140609 Date9 Apr 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20884521202419 registered 30 Sep 2026 Active
  • FDA 510(k) K140609 decided 9 Apr 2014 Active
  • FDA GUDID UDI-DI 20884521202419 listed 22 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140609
  2. Listed FDA GUDID 20884521202419
  3. Registered EUDAMED B-20884521202419

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  • Withdrawn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
RELTACK5R
Primary DI / UDI-DI
20884521202419
Basic UDI-DI
B-20884521202419
510(k) Number
FDA product code
GDW
EMDN code
H02010104 Single-use stapler cartridges for single patient
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
Size
Length — 5 Millimeter

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 (K140609)

Similar devices in this category

Other devices filed under MECHANICAL SKIN STAPLERS.

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)