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MyoSure MANUAL Tissue Removal Device
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 20-401ML
Identity
- Trade Name
- MyoSure MANUAL Tissue Removal Device EUDAMEDFDA UDI
- Generic Name
- Tissue morcellation system handpiece, line-powered FDA UDI
- Device Name
- MyoSure MANUAL Tissue Removal Device EUDAMEDThe MyoSure® Manual Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception. FDA UDI
- Model / Reference
- 20-401ML EUDAMEDFDA UDI
- Description
- The MyoSure® Manual Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception. FDA UDI
Identifiers
- Catalog Number
- 20-401ML FDA UDI
- Primary DI / UDI-DI
- 15420045507937 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455GSSMANUALTRDT8 EUDAMED
- Direct Marketing DI
- 15420045507937 EUDAMED
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- Z12080204 MORCELLATORS EUDAMED
- GMDN Term
- Tissue morcellation system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MyoSure MANUAL Tissue Removal Device by Hologic Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173901 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 54200455GSSMANUALTRDT8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000003310
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (3)
- EUDAMED 23eb61eb-3a50-4d2b-94c8-73338799cf67 61 fields · synced Jul 10, 2026
- FDA UDI b59338aa-6ad5-435d-9913-02af30a8f13a 35 fields · synced May 30, 2026
- FDA 510(k) K173901 1 fields · synced May 18, 2026