Identity
- Trade Name
- Unicare Manipulator FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Model / Reference
- 100041 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B248100041 FDA UDI
- 510(k) Number
- K163214 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Uterine manipulator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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: Uterine manipulator, single-use
Unicare Manipulator by Clearpath Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uterine manipulator, single-use.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
- ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- CerviGrip Uterine Manipulator — Surgitools Pty , Ltd. · Class II
- ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- blueendo — TROKAMED GmbH · Class II
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
- Advincula Delineator Uterine Manipulator — CooperSurgical, Inc. · Class II
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc. · Class II
Cleared under the same submission
K163214 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 |
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Manufacturer
- Manufacturer
- Clearpath Surgical, Inc.
Sources (1)
- FDA UDI b1c2ed17-cc1a-421f-94eb-6d46ba537034 33 fields · synced May 30, 2026