510(k) K041470
- Device
- MORTON IUI CATHETERS
- Applicant
- Fertility Technology Resources, Inc.
- 510(k) number
- K041470
- Product code
- MQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-11-22
- Date received
- 2004-06-02
- 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
- Statement
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- CONSTANCE W STURGEON
- Address
- 4343 Shallowford Rd. Suite D-4 Marietta GA US 30062 30062
FDA Registration Numbers
- 1450662
- 3007800906
- 1825146
- 3009756327
- 3015136743
- 3003775072
- 1221433
- 1450908
- 3014755376
- 3003995932
- 9610632
- 1422634
- 3014295858
- 3015453963
- 9617744
- 3005941719
- 3008876063
- 3005580113
- 9612445
- 1018470
- 1216677
- 3010155661
- 3017247483
- 3017896194
- 3043639843
- 3005136445
- 1047843
- 3030447506
- 8043478
- 3008456389
- 2246552
- 3009337401
- 1000393132
- 1820334
- 1424263
- 3005987240
- 9611680
- 3015140190
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Other 510(k) Records For Product Code MQF
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|---|---|---|---|
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| 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 |