Genx Embryo Transfer Catheter CC Glider
by <Genx> Intl., Inc. 510(k)
Active
510(k) K991266
Overview
The Genx Embryo Transfer Catheter CC Glider is a Catheter, Assisted Reproduction (per FDA nomenclature) designed for the transfer of embryos into the uterus during in vitro fertilization (IVF) or other assisted reproductive procedures. It features a dual-lumen design with an inner catheter (5 French) and an outer catheter (9 French tapering to 7 French) to facilitate precise placement and ease of use in standard or challenging transfer scenarios.
This device is supplied as a single-use, non-sterile catheter intended for clinical use in obstetrics and gynecology settings. It is classified as a Class II medical device under FDA regulations (884.6110) and holds a 510(k) clearance (K991266) for substantial equivalence. Storage and handling follow standard aseptic protocols prior to use, with no MRI safety restrictions noted.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991266 | Date9 Sep 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MQF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.6110
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from <Genx> Intl., Inc.
Questions
What is the primary purpose of the Genx Embryo Transfer Catheter CC Glider, and how does its design support embryo transfer procedures?
The Genx Embryo Transfer Catheter CC Glider is specifically designed for transferring embryos into the uterus during in vitro fertilization (IVF) or other assisted reproductive procedures. Its dual-lumen design—featuring an inner catheter (5 French) and an outer catheter (9 French tapering to 7 French)—enables precise placement and improved maneuverability, making it suitable for both standard and challenging transfer scenarios.
Is the Genx Embryo Transfer Catheter CC Glider intended for single-use or reusable applications, and what does this mean for clinical workflow?
The device is explicitly labeled as a single-use catheter, meaning it is intended for one-time clinical use only. This design choice aligns with standard aseptic protocols in obstetrics and gynecology, reducing the risk of cross-contamination and ensuring patient safety. Clinicians must follow manufacturer guidelines for proper handling and disposal after use.
What storage and handling precautions should be taken with the Genx Embryo Transfer Catheter CC Glider before clinical use?
The catheter is supplied in a non-sterile state, so it must undergo standard aseptic preparation (e.g., sterilization or disinfection) prior to use in the clinical setting. Since it is single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until ready for preparation. No MRI safety restrictions are noted, but adherence to manufacturer instructions for terminal sterilization or cleaning is critical.
Does the Genx Embryo Transfer Catheter CC Glider come in multiple sizes or models, and how might this affect selection for a patient?
The device data does not specify variable sizes or models beyond its dual-lumen design (5F inner/9F outer tapering to 7F). However, the product code (MQF) and FDA classification (Catheter, Assisted Reproduction) suggest it is standardized for general use in embryo transfer procedures. Clinicians typically select based on patient-specific anatomy or procedural requirements, but no additional sizing options are detailed in the provided information.