---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-040514"
form_type: "8-K"
ticker: "FEMY"
cik: "0001339005"
company_name: "FEMASYS INC"
filed_at: "2024-09-09T23:59:59+00:00"
generated_at: "2026-05-31T05:51:45.444387+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Femasys receives FDA 510(k) clearance for FemChec fallopian tube diagnostic

## Summary
- FemChec cleared by FDA for controlled contrast delivery to check tubal status.
- FemChec is also used as confirmation test after FemBloc non-surgical permanent birth control.
- FemBloc is in late-stage FINALE pivotal trial, currently enrolling.
- FemChec uses natural contrast and ultrasound, avoiding x-ray dye and radiation exposure.
- CEO Kathy Lee-Sepsick says clearance strengthens women's health product suite.

## SEC filing metadata
- accession: 0001140361-24-040514
- form_type: 8-K
- ticker: FEMY
- cik: 0001339005
- company_name: FEMASYS INC
- filed_at: 2024-09-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1339005/000114036124040514/0001140361-24-040514-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1339005/000114036124040514/ef20035640_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-040514
- JSON: https://secwatch.observer/filing/0001140361-24-040514.json
- Plain text: https://secwatch.observer/filing/0001140361-24-040514.txt

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