CooperSurgical Embryo Transfer Catheter, Assisted Reproduction Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023379 FDA 510(k)
- FDA Product Code
- MQF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6110 FDA 510(k)
- Regulation Number
- 884.6110 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Catheter, Assisted Reproduction as classified by the FDA, designed for embryo transfer during assisted reproductive procedures. It facilitates the precise placement of embryos into the uterine cavity, supporting in vitro fertilization (IVF) and other reproductive technologies. The catheter features a soft-tipped design to minimize trauma to the uterine lining, enhancing procedural comfort and success rates. Its construction includes a formable outer sheath to accommodate varying patient anatomies, ensuring adaptability during clinical use.
The CooperSurgical Embryo Transfer Catheter is supplied as a sterile, single-use device intended for use in clinical settings such as fertility clinics and reproductive medicine centers. It is classified under FDA regulation 884.6110 and holds a 510(k) clearance (K023379) with a decision of Substantially Equivalent by the Obstetrics/Gynecology Advisory Committee. The device is compatible with ultrasound guidance systems, including the SureView range, and is available in multiple reference codes for global distribution. Storage and handling follow standard sterile medical device protocols.
Frequently asked questions
What is the CooperSurgical Embryo Transfer Catheter used for?
The CooperSurgical Embryo Transfer Catheter is designed specifically for embryo transfer during assisted reproductive procedures, such as in vitro fertilization (IVF). It facilitates the precise placement of embryos into the uterine cavity, minimizing trauma to the uterine lining with its soft-tipped design. This adaptability supports higher procedural comfort and success rates for patients undergoing fertility treatments.
How is the CooperSurgical Embryo Transfer Catheter supplied and what are its sterility and usage guidelines?
The catheter is supplied as a sterile, single-use device, ensuring safety and compliance with clinical standards for assisted reproduction procedures. It is intended exclusively for use in controlled settings like fertility clinics and reproductive medicine centers. Sterility is maintained through standard medical device packaging, and it must not be reused to prevent contamination or compromise of sterility.
What reference codes or models are available for the CooperSurgical Embryo Transfer Catheter?
The device is available in multiple reference codes for global distribution, including but not limited to: 3030447506, 3005136445, 1047843, 3002807038, and others listed under the registration numbers. These variations allow clinicians to select the appropriate model based on patient-specific needs and procedural requirements, ensuring adaptability to different anatomies.
Can the CooperSurgical Embryo Transfer Catheter be used with ultrasound guidance systems?
Yes, the catheter is compatible with ultrasound guidance systems, including the CooperSurgical SureView range. This compatibility enhances procedural accuracy by allowing real-time visualization of the catheter’s placement within the uterine cavity, improving the precision of embryo transfer.
What storage and handling protocols should be followed for the CooperSurgical Embryo Transfer Catheter?
The catheter must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original, unopened packaging until immediate use, protecting it from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions. Proper storage ensures sterility and functionality for clinical procedures.
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: Wallace® Classic - CooperSurgical, Embryo Transfer - CooperSurgical, PDF Embryo Transfer Catheters - brandlab.coopersurgical.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023379 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cooper Surgical
Sources (1)
- FDA 510(k) K023379 24 fields · synced Oct 1, 2026