Identity
- Trade Name
- i-Cut FDA UDI
- Generic Name
- Tissue morcellation system handpiece, line-powered FDA UDI
- Device Name
- The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures. FDA UDI
- Model / Reference
- ICT5011 FDA UDI
- Description
- The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures. FDA UDI
Identifiers
- Catalog Number
- ICT5011 FDA UDI
- Primary DI / UDI-DI
- EAMIICT50110 FDA UDI
- 510(k) Number
- K243821 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Tissue morcellation system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 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
Yes
FDA UDI
Category: Tissue morcellation system handpiece, line-powered
i-Cut by AMI Agency for Medical Innovations GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- AMI Agency for Medical Innovations GmbH
Sources (1)
- FDA UDI d76bb0e5-dc63-4eab-846f-24e5e528ffa6 36 fields · synced Jun 8, 2026