Uterine Explora Curette - Model II
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Uterine Explora™ EUDAMEDUterine Explora Curette - Model II FDA UDIUterine Explora Curette - Model I FDA UDI
- Generic Name
- Fixed-diameter cervical dilator, single-use FDA UDI
- Device Name
- Pipelle® Endometrial Suction Curette EUDAMED3mm OD Curette with Vacu-Lok Syringe FDA UDI4mm OD Curette with Vacu-Lok Syringe FDA UDI
- Model / Reference
- MX130 EUDAMEDFDA UDIMX120 EUDAMEDFDA UDIMX124 EUDAMEDFDA UDI8200 EUDAMED
- Description
- 3mm OD Curette with Vacu-Lok Syringe FDA UDI4mm OD Curette with Vacu-Lok Syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937003529 EUDAMEDFDA UDI00888937003505 EUDAMEDFDA UDI00888937003512 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD062ZR EUDAMED
- 510(k) Number
- K001545 FDA UDI
- FDA Product Code
- HHK FDA UDI
- EMDN Code
- U089010 UTERINE CURETTES, SINGLE-USE EUDAMED
- GMDN Term
- Fixed-diameter cervical dilator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1175 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
Category: Fixed-diameter cervical dilator, single-use
Uterine Explora Curette - Model II by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-diameter cervical dilator, single-use.
- Gynex — GYNEX CORPORATION · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- Gynex — GYNEX CORPORATION · Class I
- Centurion — Centurion Medical Products · Class II
- Centurion — Centurion Medical Products · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Centurion — Centurion Medical Products · Class II
Cleared under the same submission
K001545 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (6)
- FDA UDI d6c56896-8cc6-45e7-8dcd-130a1944586c 35 fields · synced Sep 17, 2026
- FDA UDI 2c404a9e-048b-4750-b468-270badb9225d 35 fields · synced May 30, 2026
- FDA UDI 026385e4-cea3-409a-bfa7-dec60467ae09 35 fields · synced May 30, 2026
- EUDAMED af428a66-9238-4ff3-b7d1-c11b145018ce 61 fields · synced Jul 9, 2026
- EUDAMED 5eebb943-e31b-4e9e-a291-42fa937257fe 61 fields · synced Jul 17, 2026
- EUDAMED c859fa7a-0b40-4b0e-ad14-95e20fadb19d 61 fields · synced Sep 17, 2026