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TruClear 7209808

by Covidien LP

Ref 7209808

TruClear 7209808 is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 0763000B00005958C), cleared under FDA 510(k) K132015 on 13 Dec 2013 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2019 (UDI-DI 10884521749931), active as of 7 Nov 2026. One FDA recall is linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132015

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00005958C Basic UDI-DI 10884521749931UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521749931 UDI-DI Date21 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132015 Date13 Dec 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00005958C registered 23 Oct 2026 Active
  • FDA 510(k) K132015 decided 13 Dec 2013 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521749931 listed 21 Sep 2019 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1467-2022 FDA Class II initiated 7 Jun 2022

    Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

Timeline

5 dated events

  1. Cleared FDA 510(k) K031787
  2. Cleared FDA 510(k) K132015
  3. Listed FDA GUDID 10884521749931
  4. Recall initiated FDA recalls Z-1467-2022
  5. Registered EUDAMED 0763000B00005958C

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  • Withdrawn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
TruClearTM EUDAMED
TruClear GUDID
Generic name
Tissue morcellation system
Device name
TruClear™ Control Unit
Model / reference
7209808
Primary DI / UDI-DI
10884521749931
Basic UDI-DI
0763000B00005958C
Direct marketing DI
10884521749931
510(k) Number
FDA product code
HIH
EMDN code
Z12020704 Hysteroscopes
GMDN term
Tissue morcellation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1690
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 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 morcellation system

Similar devices in this category

Other devices filed under HYSTEROSCOPES.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)