Identity
- Trade Name
- MyoSure Control Unit EUDAMEDMyoSure Tissue Removal System Control Unit FDA UDI
- Generic Name
- Tissue morcellation system FDA UDI
- Device Name
- MyoSure Control Unit EUDAMEDThe MyoSure®Tissue Removal System is intended for hysteroscopic intrauterine resection procedures by a trained gynecologist to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception. FDA UDI
- Model / Reference
- 10-550 EUDAMEDFDA UDI
- Description
- The MyoSure®Tissue Removal System is intended for hysteroscopic intrauterine resection procedures by a trained gynecologist to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception. FDA UDI
Identifiers
- Catalog Number
- 10-550 FDA UDI
- Primary DI / UDI-DI
- 15420045505124 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455GSSMYOSURECTRL5B EUDAMED
- Direct Marketing DI
- 15420045505124 EUDAMED
- 510(k) Number
- K152723 FDA UDI
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- Z12080204 MORCELLATORS EUDAMED
- GMDN Term
- Tissue morcellation system FDA UDI
Classification
- Device Class
- Class IIb 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
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MyoSure Control Unit by Hologic Inc. — Class IIb — 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 | K120593 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 54200455GSSMYOSURECTRL5B | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000003310
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (3)
- EUDAMED b4c5dd4a-e75b-44b5-88f8-74e116030235 61 fields · synced Jul 22, 2026
- FDA UDI 10443041-f914-4cce-a97a-578efb08de6b 36 fields · synced May 30, 2026
- FDA 510(k) K120593 1 fields · synced May 18, 2026