Identity
- Trade Name
- MyoSure Tissue Removal Device FDA UDI
- Generic Name
- Tissue morcellation system FDA UDI
- Device Name
- 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
- Model / Reference
- 10-401 FDA 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
- 10-401 FDA UDI
- Primary DI / UDI-DI
- 15420045504813 FDA UDI
- 510(k) Number
- K142029 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Tissue morcellation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Tissue morcellation system
MyoSure Tissue Removal Device by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system.
- SUPERCUT — Karl Storz GmbH & Co. KG · Class II
- TruClear — Covidien LP · Class II
- VersaCut Sterile Outer Blade — Lumenis · Class II
- MultiCut Solo — Asclepion Laser Technologies GmbH · Class II
- MultiCut Blade 400 — Asclepion Laser Technologies GmbH · Class II
- BLUEENDO — TROKAMED GmbH · Class II
- Versacut Tissue Morcellator — Lumenis · Class II
- BLUEENDO — TROKAMED GmbH · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 27c97822-fdfe-4b60-a231-e9708f780ba1 35 fields · synced May 30, 2026