Otrieva Tapered Ovum Aspiration Needle Single Lumen
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Ovum Aspiration Needle Single Lumen EUDAMED
- Model / Reference
- K-OPS-6035-RWH-ET EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00827002197152 EUDAMED
- Basic UDI-DI
- B-00827002197152 EUDAMED
- 510(k) Number
- K141365 FDA 510(k)
- FDA Product Code
- MQE FDA 510(k)
- EMDN Code
- U08020201 SINGLE LUMEN NEEDLES AND SETS/SYSTEMS FOR OOCYTE RETRIEVAL EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6100 FDA 510(k)
- Regulation Number
- 884.6100 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Otrieva Tapered Ovum Aspiration Needle Single Lumen is a needle, assisted reproduction, designed for ovum aspiration procedures in assisted reproductive technologies. This device features a single lumen, tapered design optimized for precise retrieval of oocytes during in vitro fertilization (IVF) or similar fertility treatments.
Supplied as a single-use device, the needle is intended for use in clinical settings under sterile conditions. It is classified as a Class II medical device under FDA regulations (21 CFR 884.6100) and has received FDA 510(k) clearance and MDD authorization. The device is not MRI-safe and must be handled according to manufacturer guidelines to ensure proper functionality and sterility.
Frequently asked questions
What specific fertility procedures is this needle designed to assist with, and how does its tapered design benefit the process?
The Otrieva Tapered Ovum Aspiration Needle is specifically designed for ovum (oocyte) aspiration during in vitro fertilization (IVF) and similar assisted reproductive technologies. Its tapered design is optimized for precise retrieval of oocytes, reducing trauma to surrounding tissues and improving accuracy during the procedure. This design helps minimize discomfort for patients and enhances the success rate of oocyte collection.
Is this needle reusable, or is it intended for single-use only? How should it be handled to maintain sterility?
This device is intended for single-use only and must be used in clinical settings under sterile conditions. Since it is a sterile, single-lumen needle, it should be handled with care to avoid contamination. Follow the manufacturer’s guidelines to ensure proper functionality and sterility, including proper packaging storage and disposal after use.
What sizes or models of this needle are available, and how do I determine the correct one for a patient?
The Otrieva Tapered Ovum Aspiration Needle comes in multiple sizes, as indicated by the OpenFDA registration numbers (e.g., 3002807038, 3005580113, etc.). The correct size depends on clinical factors such as patient anatomy and procedural requirements. Consult the manufacturer’s documentation or a fertility specialist to select the appropriate model for optimal performance during ovum aspiration.
Can this needle be used in an MRI environment, or are there any special handling instructions related to imaging?
The Otrieva Tapered Ovum Aspiration Needle is not MRI-safe, meaning it should not be used in an MRI environment. If MRI imaging is required for the patient post-procedure, the needle must be fully removed before entering the MRI scanner. Always follow the manufacturer’s guidelines to ensure patient safety and device integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141365 | Class II | Active |
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Manufacturer
- Manufacturer
- William A. Cook Australia Pty. Ltd.
- FDA Applicant
- William A. Cook Australia Pty. , Ltd.
Sources (2)
- FDA 510(k) K141365 24 fields · synced Sep 30, 2026
- EUDAMED 7f511413-ea4e-48a3-81af-bad7d1f7f864 61 fields · synced Sep 17, 2026