Femcerv Endocervical Sampler (3 Sizes: Ref Fcv-013 +2 more)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Femasys Inc.
Identifiers
- 510(k) Number
- K122658 FDA 510(k)
- FDA Product Code
- PCF FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1050 FDA 510(k)
- Regulation Number
- 884.1050 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FemCerv Endocervical Sampler Model 3 is a Sampler, Endocervical (per OpenFDA nomenclature), designed for the collection of endocervical samples. This device is classified as a Class II medical device under FDA regulations (884.1050) and is intended for use in obstetrics and gynecology procedures.
The sampler is available in three reference sizes: FCV-013, FCV-011, and FCV-009, and is supplied as a single-use device. It has received FDA 510K clearance and MDR authorization, with a decision classification of Substantially Equivalent (SESE) under the Obstetrics/Gynecology advisory committee. Storage and handling instructions are not specified in the data, but compliance with standard aseptic practices is implied for single-use medical devices.
Frequently asked questions
What are the available sizes for the FemCerv Endocervical Sampler Model 3, and how does this affect its use?
The FemCerv Endocervical Sampler Model 3 comes in three reference sizes: FCV-013, FCV-011, and FCV-009. These sizes are likely designed to accommodate different patient anatomies or clinical scenarios, ensuring proper placement and sample collection during endocervical procedures. The choice of size may depend on clinician preference, patient-specific factors, or the specific diagnostic or screening protocol being followed.
Is the FemCerv Endocervical Sampler Model 3 intended for single-use or reusable applications, and what does this mean for clinical workflow?
The FemCerv Endocervical Sampler Model 3 is explicitly supplied as a single-use device. This means each sampler is intended for one-time use in a single patient procedure, reducing the risk of cross-contamination and ensuring patient safety. Clinicians should follow standard aseptic practices for single-use devices, including proper disposal after use and preparing a new, sterile sampler for subsequent procedures.
What regulatory pathways has the FemCerv Endocervical Sampler Model 3 followed, and what does this imply for its use in clinical settings?
The FemCerv Endocervical Sampler Model 3 has received FDA 510(k) clearance and MDR authorization, with a classification of Substantially Equivalent (SESE) under the Obstetrics/Gynecology advisory committee. This implies that the device has been evaluated and deemed comparable to a legally marketed predicate device in terms of safety and effectiveness for its intended use in obstetrics and gynecology procedures. Clinicians can rely on this regulatory clearance as evidence of the device’s compliance with applicable standards.
How should clinicians determine which size of the FemCerv Endocervical Sampler Model 3 to use for a specific patient?
The decision on which size to use (FCV-013, FCV-011, or FCV-009) should be based on clinical judgment, patient anatomy, and the specific diagnostic or screening protocol being followed. While the data does not specify exact sizing guidelines, clinicians typically select the sampler size that best fits the patient’s cervical canal to ensure effective sample collection. Manufacturer guidelines or additional clinical literature may provide further context for size selection.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K122658 | Class II | Active |
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Manufacturer
- Manufacturer
- Femasys Inc.
- FDA Applicant
- Femasys, Inc.
Sources (2)
- FDA 510(k) K122658 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026