Double Lumen Ovum Aspiration Needles
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Ovum Aspiration Needle Double Lumen EUDAMED
- Device Name
- Double Lumen Ovum Pick-Up Needles EUDAMED
- Model / Reference
- K-OPSD-1735-A-L EUDAMEDK-OPSD-1730-A-L EUDAMEDK-OPSD-1630-B-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00827002304611 EUDAMED00827002304635 EUDAMED00827002304116 EUDAMED
- Basic UDI-DI
- B-00827002304611 EUDAMEDB-00827002304635 EUDAMEDB-00827002304116 EUDAMED
- 510(k) Number
- K171611 FDA 510(k)
- FDA Product Code
- MQE FDA 510(k)
- EMDN Code
- U08020202 DOUBLE 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
- Italy EUDAMEDBelgium 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 Double Lumen Ovum Aspiration Needles are needles, assisted reproduction (per FDA nomenclature), designed for the aspiration and flushing of oocytes from ovarian follicles during assisted reproductive procedures. Their double-lumen design enables simultaneous or sequential aspiration and flushing of follicular contents, improving procedural efficiency. The echogenic tip enhances ultrasound visualization, aiding precise guidance during transvaginal or laparoscopic use.
These needles are single-use, sterile, and supplied sterile for clinical use in obstetrics/gynecology settings. They are Class II devices under FDA regulations (21 CFR 884.6100) and comply with the Medical Devices Directive (MDD). Available in multiple sizes (as referenced by FEI numbers), they require proper storage in a clean, dry environment to maintain sterility. Authorized via FDA 510(k) clearance (K171611) and MDD compliance, they are intended for use in controlled clinical environments adhering to reproductive medicine protocols.
Frequently asked questions
What specific assisted reproductive procedures are these needles designed to support during oocyte aspiration?
These Double Lumen Ovum Aspiration Needles are specifically designed for the aspiration and flushing of oocytes (eggs) from ovarian follicles during assisted reproductive procedures, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The double-lumen design allows for simultaneous or sequential aspiration and flushing of follicular contents, enhancing efficiency and precision during transvaginal or laparoscopic follicle retrieval.
Are these needles reusable, or are they intended for single-use only? How does this affect their handling?
These needles are explicitly intended for single-use only, as stated in the manufacturer’s description. This design ensures sterility and reduces the risk of cross-contamination between patients. Clinicians must adhere to single-use protocols, discarding the needle immediately after use and following proper disposal procedures to maintain infection control standards.
What storage conditions are required to maintain the sterility of these needles before clinical use?
The needles must be stored in a clean, dry environment to preserve sterility, as specified in the manufacturer’s instructions. Avoid exposure to moisture, extreme temperatures, or contamination. The packaging should remain intact until immediate use, and any opened or compromised packaging should be discarded to prevent compromise of sterile integrity.
How do the echogenic tips on these needles improve the procedural workflow during oocyte aspiration?
The echogenic tips enhance ultrasound visualization, allowing clinicians to precisely guide the needle during transvaginal or laparoscopic follicle aspiration. This feature reduces procedural uncertainty, minimizes follicle puncture risks, and improves the accuracy of oocyte retrieval, particularly in challenging anatomical cases.
What sizes or models are available for these needles, and how might a clinician determine the appropriate choice?
These needles are available in multiple sizes, each referenced by unique FEI numbers (e.g., 3007530363, 3005136445, etc.). The selection depends on clinical factors like follicle size, patient anatomy, and procedural approach (e.g., transvaginal vs. laparoscopic). Consulting the manufacturer’s sizing guidelines or product catalog—linked to the listed FEI numbers—can help clinicians match the needle to the specific case requirements.
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. Sources consulted: Cook® EchoTip® Double Lumen Aspiration Needle, PDF Double Lumen Ovum Aspiration 2 Needle (K-OPSD series) - Cook Medical, Double Lumen Ovum Aspiration Needles (K171611) - Innolitics
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 | K171611 | Class II | Active |
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Manufacturer
- Manufacturer
- William A. Cook Australia Pty. Ltd.
- FDA Applicant
- William A. Cook Australia Pty. , Ltd.
Sources (4)
- FDA 510(k) K171611 24 fields · synced Sep 18, 2026
- EUDAMED efe7cb8f-3ed8-4471-b59c-e73c5a93f6bf 61 fields · synced Jul 23, 2026
- EUDAMED 73ba08b6-3892-430c-83ec-452b6b874318 61 fields · synced Jul 24, 2026
- EUDAMED 2f14fc4b-8867-4fa3-9805-5bbc1d3e9e6e 61 fields · synced Jul 26, 2026