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MyoSure XL Tissue Removal Device for Fluent

by Hologic, Inc.

Ref 50-601XL

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

CE MDR 510(k)

Valid until

Not listed

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) K181974↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number54200455GSSMYOSURETRDQK Basic UDI-DI 15420045507654UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045507654 UDI-DI Date26 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK181974 Date23 Aug 2018IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
MyoSure XL Tissue Removal Device for Fluent EUDAMED
Myosure XL for Fluent Device GUDID
Generic Name
Tissue morcellation system
Device Name
MyoSure REACH Tissue Removal Device; MyoSure LITE Tissue Removal Device; MyoSure XL Tissue Removal Device; MyoSure XL Tissue Removal Device for Fluent
Model / Ref / Catalog
50-601XL
Primary DI / UDI-DI
15420045507654
Basic UDI-DI
54200455GSSMYOSURETRDQK
Direct Marketing DI
15420045507654
510(k) Number
FDA Product Code
HIH
EMDN Code
Z12080204 Morcellators
GMDN Term
Tissue morcellation system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
884.1690
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000003310
Authorised representative
Hologic BV BE-AR-000000127

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See all devices from Hologic →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No