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VersaCut+ Tissue Morcellator with Regular Handpiece
FDA UDIClass II (US FDA UDI)
by Lumenis
Identity
- Trade Name
- VersaCut+ Tissue Morcellator with Regular Handpiece FDA UDI
- Generic Name
- Tissue morcellation system handpiece, line-powered FDA UDI
- Model / Reference
- VersaCut+ Tissue Morcellator with Regular Handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109140643 FDA UDI
- 510(k) Number
- K133272 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Tissue morcellation system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tissue morcellation system handpiece, line-powered
VersaCut+ Tissue Morcellator with Regular Handpiece by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system handpiece, line-powered.
- Aveta Disposable Resecting Device 2.9 mm — Meditrina, Inc. · Class II
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- Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class I
- Polyp Traps — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- 2-piece Cleaning Adapter + 4-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class IIa
- Guide Wires — Changzhou Health Microport Medical Device Co., Ltd · Class IIa
- Aveta Disposable Resecting Device 3.9 mm — Meditrina, Inc. · Class II
- 3-piece valve kit — GA HEALTH COMPANY LIMITED · Class I
Cleared under the same submission
K133272 also covers:
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
- Lumenis
Sources (1)
- FDA UDI d3ba885f-c583-48bf-b80e-b7a16f50fc16 34 fields · synced May 31, 2026