FemVue® Controlled Saline-Air Device is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

Device Description

The FemVue® Controlled Saline-Air Device is a sterile dual-barrel contrast media syringe that is connected to an intrauterine catheter to instill saline-air contrast medium as part of a sono-hysterosalpingogram (Sono-HSG) procedure. Ultrasound of the fallopian tubes can be performed with or without assessment of the uterine cavity.

The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via ethylene oxide (EO) sterilization and is intended for single-use.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - FemVue® Controlled Saline-Air Device

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

December 15, 2025

Femasys, Inc.
Christine Thomas
Chief Regulatory and Clinical Officer
3950 Johns Creek Court, Suite 100
Cumming, GA 30041

Re: K253403
Trade/Device Name: FemVue® Controlled Saline-Air Device (FSA-300)
Regulation Number: 21 CFR§ 884.4530
Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument
Regulatory Class: II
Product Code: LKF
Dated: September 29, 2025
Received: September 30, 2025

Dear Christine Thomas:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K253403 - Christine Thomas
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K253403 - Christine Thomas
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K253403
Please provide the device trade name(s).

FemVue® Controlled Saline-Air Device (FSA-300)

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).	☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K253403
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510(k) Summary – K253403

I. SUBMITTER

Applicant: Femasys Inc.

Applicant Address: 3950 Johns Creek Court, Suite 100
Suwanee, GA 30024

Phone: +770-500-3910 x137

Email: CThomas@femasys.com

Contact Person: Christine Thomas
Chief Regulatory, Quality and Clinical

Date Prepared: December 3, 2025

II. DEVICE

Trade Name: FemVue® Controlled Saline-Air Device

Common Name: Contrast media syringe

Regulation Name: Obstetric-gynecologic specialized manual instrument

Regulation Number: 21 CFR 884.4530

Regulatory Class: II

Product Code: LKF (Cannula, Manipulator/Injector, Uterine)

III. PREDICATE DEVICE

FemChec® Controlled Saline-Air Device (K241693), manufactured by Femasys Inc.

The predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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K253403
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V. INDICATIONS FOR USE

VI. COMPARISON OF THE INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES

The indications for use and key technological characteristics of the subject and predicate device are compared in the table below.

Table 1. Indications for use and technological characteristics comparison.

Comparison Item	FemVue® Controlled Saline-Air DeviceSubject Device	FemChec® Controlled Saline-Air DevicePredicate Device
Submission Number	K253403	K241693	N/A
Regulation	21 CFR 884.4530	21 CFR 884.4530	Same
Device Classification	Class II	Class II	Same
Product Code	LKF	LKF	Same
Product Code Description	Cannula, Manipulator/Injector, Uterine	Cannula, Manipulator/Injector, Uterine	Same
Regulation Name	Obstetric-gynecologic specialized manual instrument	Obstetric-gynecologic specialized manual instrument	Same
Indications for Use	FemVue® Controlled Saline-Air Device is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).	The FemChec® is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).	Same apart from Trade Name
Design Feature	Dual-barrel contrast media syringe that can be connected to an intrauterine catheter.	Dual-barrel contrast media syringe that can be connected to an intrauterine catheter.	Same
Prescription Only	Yes	Yes	Same
Catheter Luer Connection	Spin Luer	Spin Luer	Same
Plunger Control Feature	Ratcheted Plunger Design	Ratcheted Plunger Design	Same

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K253403
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Contrast Viewing Window	Contrast bubbles viewed through neck of luer	Contrast bubbles viewed through window in device	Different: The different viewing location of the contrast bubbles do not raise different questions of safety and effectiveness.

Both the subject device and predicate device are a dual-barrel contrast media syringe intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media through a connected intrauterine catheter into the uterus and fallopian tubes for performance of sono-hysterosalpingogram (Sono HSG) procedure. Both devices designed and manufactured by Femasys Inc. are of the same materials and are fundamental design, are single use only and sterilized via ethylene oxide (EO).

The subject does not have a viewing window, unlike the predicate device, but has the same design as the FDA cleared FemVue (K110288) and FemVue MINI (K242002) devices, with the same intended use. The difference does not raise different questions of safety and effectiveness.

VII. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

The following studies have been performed to support substantial equivalence to the predicate device. Due to the similar device design and packaging, test methods and data from the predicate device are leveraged to support the subject device:

Ethylene Oxide Sterilization Validation testing per:
- ISO 11135:2014
- AAMI TIR 28:2016
- ISO 10993-7: 2008
Package Integrity testing:
- Visual inspection
- Bubble Leak test per ASTM F2096-11
- Seal Strength testing per ASTM F88/ F88M-23
Transportation Simulation testing per ASTM D4169-22
Biocompatibility studies conducted in accordance with the 2023 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." For devices in indirect contact with mucosal tissues. Testing included the following assessments:
- Cytotoxicity per ISO 10993-5: 2009
- Sensitization per ISO 10993-10: 2021
- Irritation per ISO 10993-23: 2021

Testing showed the device material to be non-cytotoxic, non-sensitizing, and non-irritating.

Bench performance studies before and after accelerated aging to the equivalent of 4.6 years

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of real-time aging in accordance with ASTM F1980-21 demonstrated that all predetermined acceptance criteria were met in the following tests:

Visual Inspection
Functional/Cycle Testing
Saline-Air Quantification

VIII. CONCLUSIONS

The results of the testing described above demonstrate that the FemVue Controlled Saline-Air Device is as safe and effective as the predicate device and supports a determination of substantial equivalence to the predicate device.

Regulation Number and Section

§ 884.4530 Obstetric-gynecologic specialized manual instrument.

(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.