Transem and EchoGen Embryo Transfer Catheters
FDA 510(k) K161547 · Origio A/S
510(k) numberK161547
Submission
- Device name
- Transem and EchoGen Embryo Transfer Catheters
- Applicant
- Origio A/S
Måløv, DK - Received
- June 3, 2016
- Decision date
- March 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter…MQF · Special | Cook Incorporated | 05/17/2019SE |
| K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator…MQF · Traditional | Cook Incorporated | 10/24/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K200815 | VitriGuardMQK · Traditional | 06/25/2020SE |
| K180740 | VitriGuardMQK · Special | 05/04/2018SE |
| K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red…MQL · Traditional | 03/02/2018SE |
| K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSMQL · Traditional | 10/13/2017SE |
| K162833 | VitriGuardMQK · Traditional | 02/16/2017SE |
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashMQL · Traditional | 07/22/2016SE |
| K152932 | BlastGenMQL · Traditional | 02/29/2016SE |
| K140317 | EmbryogenMQL · Traditional | 06/16/2014SE |
| K133912 | Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav…MQL · Traditional | 05/14/2014SE |
| K133387 | Origio(R) Sequential Blast TM; Origio(R) Sequential Blast TM with Phenol RedMQL · Traditional | 04/29/2014SE |
Questions and answers
When was Transem and EchoGen Embryo Transfer Catheters cleared by the FDA?
Transem and EchoGen Embryo Transfer Catheters (K161547) received a 510(k) decision of Substantially Equivalent on March 9, 2017, 279 days after the submission was received.
What is the product code of K161547?
The FDA product code is MQF – Catheter, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6110.