FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
K Number: K243373
·
Decision Jul 23, 2025
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
52
Applicant Total
38
Review Days
266
Basic Information
- Device Name
- Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
- K Number
- K243373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6110
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vitrolife Sweden AB
- Date Received
- October 30, 2024
- Decision Date
- July 23, 2025
- Product Code
- MQF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQF | Catheter, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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