510(k) K253403
- Device
- FemVue® Controlled Saline-Air Device (FSA-300)
- Applicant
- Femasys, Inc.
- 510(k) number
- K253403
- Product code
- LKF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-15
- Date received
- 2025-09-30
- Regulation
- 884.4530
- Classification name
- Cannula, Manipulator/Injector, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Christine Thomas
- Address
- 3950 Johns Creek Ct. Suite 100 Cumming GA US 30041 30041
FDA Registration Numbers
- 3036773433
- 1450662
- 2084346
- 3013283620
- 1825146
- 1412854
- 3015895045
- 3003968049
- 3004727093
- 2183744
- 1644312
- 2032098
- 1018470
- 1216677
- 3009513193
- 3015142721
- 1722684
- 1718873
- 3030447506
- 3013557562
- 9610612
- 2246552
- 3010131137
- 1820334
- 1627186
- 1320468
- 2916714
- 3024860690
- 1417485
- 1625425
- 1043214
- 1055236
- 3001675293
- 3014279513
- 3007421149
- 3025325116
- 3009328501
- 3014579161
- 3008367216
- 2431166
- 1000393132
- 1319639
- 3033307563
- 3012783431
- 3010701807
- 1450908
- 3004491689
- 1720929
- 3012494290
- 2320762
- 3004215117
- 3018984
- 3015612252
- 1220477
- 3032109
- 1047843
- 3008254127
- 3004111573
- 3007800906
- 1321175
- 3010041511
- 1054241
- 9680721
- 3008571754
- 3016678045
- 9611283
- 3043226252
- 3008439467
- 3032906574
- 1421879
- 3007345416
- 3011137372
- 2528981
- 3008770252
- 3005987240
- 1320894
- 8040510
- 2125050
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code LKF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252260 | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. | 2025-11-26 |
| K242002 | FemVue MINI Saline-Air Device | Femasys, Inc. | 2024-11-22 |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | Li Medical Corporation , Ltd. | 2024-10-16 |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. | 2024-09-06 |
| K222798 | Rejoni Intrauterine Catheter | Rejoni, Inc. | 2022-12-16 |
| K223064 | ALLY II Uterine Positioning System (UPS) | CooperSurgical, Inc. | 2022-10-28 |
| K220202 | Uterine ElevatOR PRO with OccludOR Balloon | The O R Company Pty, Ltd. | 2022-03-31 |
| K212505 | DUMI ManipulatOR | The O R Company Pty, Ltd. | 2022-01-10 |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | 2019-03-29 |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | Cook Incorporated | 2018-10-26 |
| K180291 | Cook Silicone Balloon HSG Catheter | Cook Incorporated | 2018-10-26 |
| K172846 | Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute | 2018-06-26 |
| K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip | Cook Incorporated | 2018-02-15 |
| K163214 | Unicare System, Unicare Manipulator | Clearpath Surgical, Inc. | 2017-02-07 |
| K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016-10-06 |