Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter
FDA 510(k) K033084 · Portex , Ltd.
510(k) numberK033084
Submission
- Device name
- Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter
- Applicant
- Portex , Ltd.
Hyth, Kent, GB - Received
- September 29, 2003
- Decision date
- December 19, 2003
- 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 |
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| K032716 | Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)CAH · Traditional | 11/28/2003SE |
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| K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaBTO · Traditional | 08/27/2003SE |
| K031057 | Per-Fit Percutaneous Dilational Tracheostomy KitJOH · Traditional | 07/18/2003SE |
| K031622 | Wallace Dual Lumen Oocyte Retrieval SetsMQE · Traditional | 06/26/2003SE |
| K023793 | 1ST Response Intermediate Manual ResuscitatorBTM · Traditional | 02/11/2003SE |
| K014115 | 1ST Response Manual Resuscitator, Model 85XXBTM · Traditional | 02/27/2002SE |
Questions and answers
When was Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter cleared by the FDA?
Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter (K033084) received a 510(k) decision of Substantially Equivalent on December 19, 2003, 81 days after the submission was received.
What is the product code of K033084?
The FDA product code is MQF – Catheter, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6110.