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TruClear 72204064

by Covidien LP

Ref 72204064

TruClear 72204064 is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 0763000B00005707U), cleared under FDA 510(k) K161763 on 22 Nov 2016 and listed in FDA GUDID since 16 Oct 2017 (UDI-DI 10884521744097), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161763

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/MDR EUDAMED Number0763000B00005707U Basic UDI-DI 10884521744097UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521744097 UDI-DI Date16 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161763 Date22 Nov 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00005707U registered 6 Jul 2026 Active
  • FDA 510(k) K161763 decided 22 Nov 2016 Active
  • FDA GUDID UDI-DI 10884521744097 listed 16 Oct 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161763
  2. Listed FDA GUDID 10884521744097
  3. Registered EUDAMED 0763000B00005707U

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  • Withdrawn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
TruClear™ EUDAMED
TruClear GUDID
Generic name
Tissue morcellation system
Device name
TruClear Tissue Removal Shaver
Model / reference
72204064
Primary DI / UDI-DI
10884521744097
Basic UDI-DI
0763000B00005707U
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

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)