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TruClear 72204878

by Covidien LP

Ref 72204878

TruClear 72204878 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 0763000B00005447T), cleared under FDA 510(k) K180496 on 29 Aug 2018 and listed in FDA GUDID since 21 Dec 2018 (UDI-DI 10884521746633), 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) K180496

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 Number0763000B00005447T Basic UDI-DI 10884521746633UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521746633 UDI-DI Date21 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180496 Date29 Aug 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00005447T registered 6 Jul 2026 Active
  • FDA 510(k) K180496 decided 29 Aug 2018 Active
  • FDA GUDID UDI-DI 10884521746633 listed 21 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180496
  2. Listed FDA GUDID 10884521746633
  3. Registered EUDAMED 0763000B00005447T

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  • Withdrawn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
Rigid optical hysteroscope
Device name
TruClear Elite Hysteroscope Mini
Model / reference
72204878
Primary DI / UDI-DI
10884521746633
Basic UDI-DI
0763000B00005447T
Direct marketing DI
10884521746633
510(k) Number
FDA product code
HIH
EMDN code
Z12020704 Hysteroscopes
GMDN term
Rigid optical hysteroscope
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
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 6 Millimeter

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: Rigid optical hysteroscope

Cleared under the same submission (K180496)

and 2 more cleared under K180496

Similar devices in this category

Other devices filed under HYSTEROSCOPES.

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

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)