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Femeye Two

by Fem Suite, LLC 510(k)

Active United States

510(k) K093218

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093218 Date18 May 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HIH
Device Class
Class II
Regulation
21 CFR Part 884.1690
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Femeye Two is a hysteroscope device used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. It includes an integrated light source and an irrigation/working channel port. The non-disposable portion of the FemEye Two is the battery cartridge which powers the device.

The Femeye Two is supplied as part of a premarket notification filed with the FDA under product code HIH. It is a Class II device with FDA 510(k) clearance K093218, received on 2009-10-13 and decided on 2010-05-18. The device is reviewed under the Obstetrics/Gynecology advisory committee and is manufactured by Fem Suite, LLC in Sonoma, CA.

Other devices from Fem Suite, LLC

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FemEye Two used for?

    The FemEye Two is a hysteroscope device designed to permit viewing of the cervical canal and uterine cavity for performing diagnostic procedures. It includes an integrated light source and an irrigation/working channel port to facilitate these examinations.

  • How is the FemEye Two supplied and what is its sterility status?

    The FemEye Two is supplied as part of a premarket notification filed with the FDA. The device includes a non-disposable battery cartridge that powers the hysteroscope. The sterility status is not specified in the provided device data.

  • Is the FemEye Two single-use or reusable?

    The FemEye Two has a non-disposable battery cartridge component that powers the device, but the description does not specify whether the entire hysteroscope is single-use or reusable. The battery cartridge is specifically mentioned as the non-disposable portion.

  • What regulatory approvals does the FemEye Two have?

    The FemEye Two has FDA 510(k) clearance K093218, received on 2009-10-13 and decided on 2010-05-18. It is classified as a Class II device under product code HIH and was reviewed under the Obstetrics/Gynecology advisory committee.

  • Who manufactures the FemEye Two and where is it produced?

    The FemEye Two is manufactured by Fem Suite, LLC, located at 19991 7th St. E., Sonoma, CA 95476. The company is the applicant for the FDA 510(k) clearance for this device.