Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
FDA 510(k) clearance K190522 · decided 2019-11-14
Clearance details
- K-number
- K190522
- Device name
- Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
- Applicant
- Allwin Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-03-04
- Decision date
- 2019-11-14
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- MQF
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) (K253354) | Guangzhou Hehong Biotech Co., Ltd. | 2026-02-12 |
| 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) (K243373) | Vitrolife Sweden AB | 2025-07-23 |
| VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (K240307) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-08-16 |
| FemaSeed Intratubal Insemination (K231730) | Femasys, Inc. | 2023-09-22 |
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| Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators (K200248) | Allwin Medical Devices, Inc. | 2020-07-01 |
| Kitazato ET Catheters (K192540) | Kitazato Corporation | 2020-05-01 |
| 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) | Cook Incorporated | 2019-05-17 |
| Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter (K180302) | Cook Incorporated | 2018-10-24 |
| Towako Transmyometrial Embryo Transfer Set (K173431) | William A. Cook Australia Pty. , Ltd. | 2018-05-18 |
| Pivet and Soft-Pass Embryo Transfer Catheter Sets (K173103) | Cook Incorporated | 2018-04-13 |
| Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter (K173686) | Cook Incorporated | 2018-04-11 |
Recalls involving this device
No recalls on record reference this clearance.