510(k) K983591
- Device
- INTRATUBAL TRANSFER SETS
- Applicant
- COOK OB/GYN
- 510(k) number
- K983591
- Product code
- MQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-12-21
- Date received
- 1998-10-13
- Regulation
- 884.6110
- Classification name
- Catheter, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBBIE SCHMITT
- Address
- 1100 W. Morgan St. P.O. Box 271 Spencer IN US 47460 47460
FDA Registration Numbers#
- 3010155661
- 1018470
- 3037001927
- 3009756327
- 1450908
- 3014295858
- 3003995932
- 8043478
- 3005580113
- 3015140190
- 1216677
- 1450662
- 2246552
- 9617744
- 3030447506
- 3005136445
- 1221433
- 1422634
- 9612445
- 1424263
- 3043639843
- 3005987240
- 1825146
- 3007800906
- 3008456389
- 3015453963
- 1000393132
- 3017247483
- 3005941719
- 1047843
- 9611680
- 3017896194
- 3009337401
- 3003775072
- 1820334
- 9610632
- 3015136743
- 3008876063
- 3014755376
Source Documents#
Other 510(k) Records For Product Code MQF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | Guangzhou Hehong Biotech Co., Ltd. | 2026-02-12 |
| K243373 | 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) | Vitrolife Sweden AB | 2025-07-23 |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-08-16 |
| K231730 | FemaSeed Intratubal Insemination | Femasys, Inc. | 2023-09-22 |
| K220010 | Daylily Single Use Sterile Embryo Transfer Catheter | Shanghai Horizon Medical Technology Co., Ltd. | 2022-12-16 |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators | Allwin Medical Devices, Inc. | 2020-07-01 |
| K192540 | Kitazato ET Catheters | Kitazato Corporation | 2020-05-01 |
| K190522 | 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) | Allwin Medical Devices, Inc. | 2019-11-14 |
| K191015 | 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) | Cook Incorporated | 2019-05-17 |
| K180302 | Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter | Cook Incorporated | 2018-10-24 |
| K173431 | Towako Transmyometrial Embryo Transfer Set | William A. Cook Australia Pty. , Ltd. | 2018-05-18 |
| K173103 | Pivet and Soft-Pass Embryo Transfer Catheter Sets | Cook Incorporated | 2018-04-13 |
| K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | Cook Incorporated | 2018-04-11 |
| K172051 | Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter | Cook Incorporated | 2018-01-10 |
| K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters | Cook Incorporated | 2017-12-21 |
Legacy Summary#
summary
FDA Review#
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