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Advincula Delineator™ Uterine Manipulator
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SACRO-1SModel AD750-KES25
Identity
- Trade Name
- Sacrocolpopexy Tip FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Device Name
- Advincula Delineator™ Uterine Manipulator EUDAMEDSacrocolpopexy Tip - Small for Laparoscopic Vaginal Prolapse Procedures FDA UDI
- Model / Reference
- AD750-KES25 EUDAMEDSACRO-1S EUDAMEDFDA UDI
- Description
- Sacrocolpopexy Tip - Small for Laparoscopic Vaginal Prolapse Procedures FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015041 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD015sYH EUDAMED
- FDA Product Code
- HDL FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Uterine manipulator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.4520 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Advincula Delineator™ Uterine Manipulator by CooperSurgical, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
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 | K201086 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K143650 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K180429 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0888937TD015sYH | Class IIa | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (3)
- EUDAMED 46a753d3-721d-4e82-98c1-c478212bfa05 61 fields · synced Jul 9, 2026
- FDA UDI 5215bd86-7101-4774-9096-7b2fb144521d 33 fields · synced May 30, 2026
- FDA 510(k) K201086 1 fields · synced May 18, 2026