Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
FDA 510(k) K191015 · Cook Incorporated
510(k) numberK191015
Submission
- Device name
- Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- April 17, 2019
- Decision date
- May 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQF – Catheter, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6110
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…MQF · Traditional | Guangzhou Hehong Biotech Co., Ltd. | 02/12/2026SE |
| K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…MQF · Traditional | Vitrolife Sweden AB | 07/23/2025SE |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)MQF · Traditional | Shenzhen Vitavitro Biotech Co., Ltd. | 08/16/2024SE |
| K231730 | FemaSeed Intratubal InseminationMQF · Traditional | Femasys, Inc. | 09/22/2023SE |
| K220010 | Daylily Single Use Sterile Embryo Transfer CatheterMQF · Traditional | Shanghai Horizon Medical Technology Co., Ltd. | 12/16/2022SE |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsMQF · Traditional | Allwin Medical Devices, Inc. | 07/01/2020SE |
| K192540 | Kitazato ET CathetersMQF · Traditional | Kitazato Corporation | 05/01/2020SE |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra…MQF · Traditional | Allwin Medical Devices, Inc. | 11/14/2019SE |
| K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator…MQF · Traditional | Cook Incorporated | 10/24/2018SE |
| K173431 | Towako Transmyometrial Embryo Transfer SetMQF · Special | William A. Cook Australia Pty. , Ltd. | 05/18/2018SE |
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Questions and answers
When was Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) cleared by the FDA?
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) (K191015) received a 510(k) decision of Substantially Equivalent on May 17, 2019, 30 days after the submission was received.
What is the product code of K191015?
The FDA product code is MQF – Catheter, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6110.