---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-045950"
form_type: "8-K"
ticker: "FEMY"
cik: "0001339005"
company_name: "FEMASYS INC"
filed_at: "2025-12-18T23:59:59+00:00"
generated_at: "2026-05-16T12:43:03.532019+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Femasys receives FDA 510(k) clearance for next-gen FemVue Controlled device

## Summary
- FDA 510(k) clearance for FemVue Controlled, integrating FemVue and FemChec technologies.
- Single-device solution for controlled contrast delivery to evaluate fallopian tube status.
- Designed to enable multiple clinical uses and streamline manufacturing and practice workflows.
- CEO Kathy Lee-Sepsick highlights milestone as advancing clinician-focused innovations.
- NASDAQ-ticker FEMY; clearance announced December 18, 2025.

## SEC filing metadata
- accession: 0001140361-25-045950
- form_type: 8-K
- ticker: FEMY
- cik: 0001339005
- company_name: FEMASYS INC
- filed_at: 2025-12-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1339005/000114036125045950/0001140361-25-045950-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1339005/000114036125045950/ef20061522_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-045950
- JSON: https://secwatch.observer/filing/0001140361-25-045950.json
- Plain text: https://secwatch.observer/filing/0001140361-25-045950.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.