FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FemVue® Controlled Saline-Air Device (FSA-300)
K Number: K253403
·
Decision Dec 15, 2025
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
9
Review Days
76
Basic Information
- Device Name
- FemVue® Controlled Saline-Air Device (FSA-300)
- K Number
- K253403
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Femasys, Inc.
- Date Received
- September 30, 2025
- Decision Date
- December 15, 2025
- Product Code
- LKF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKF), ordered by most recent decision date.
RELIEEV HSG Catheter (HSG7FA1)
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FemVue MINI Saline-Air Device
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RELIEEV Uterine Manipulator Injector (CUMI 5.0)
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FemChec Controlled Saline-Air Device (FCD-250)
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Rejoni Intrauterine Catheter
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FDA Class 2
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ALLY II Uterine Positioning System (UPS)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Femasys, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242002 | FemVue MINI Saline-Air Device | Nov 22, 2024 | Substantially Equivalent |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Sep 6, 2024 | Substantially Equivalent |
| K231730 | FemaSeed Intratubal Insemination | Sep 22, 2023 | Substantially Equivalent |
| K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 | Dec 20, 2012 | Substantially Equivalent |
| K110993 | FEMCHEC PRESSURE MANAGEMET DEVICE | Oct 12, 2011 | Substantially Equivalent |
| K110288 | FEMVUE SALINE-AIR DEVICE | Apr 28, 2011 | Substantially Equivalent |
| K100662 | FEMVUE CORNUAL BALLOON CATHETER | Apr 7, 2010 | Substantially Equivalent |
| K083690 | FEMVUE(TM) CATHETER SYSTEM | Jun 23, 2009 | Substantially Equivalent |