Female Continence Device

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K883721 ↗

FDA Product Code

HHW

Device Class

Class II

Regulation

21 CFR Part 884.3575

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Stamey Needle

  Class I

  FDA 510(k) K884553 Active Cleared 14 Nov 1988

• Tubal Lumen Support

  Class II

  FDA 510(k) K932114 Active Cleared 27 Sep 1994

• Sholkoff Balloon Hysterosalpingography Catheter

  Class II

  FDA 510(k) K891290 Active Cleared 23 May 1989

• Bakri Postpartum Balloon, Model J-Sos-100500

  Class II

  FDA 510(k) K062438 Active Cleared 27 Oct 2006

• Balloon Dilation Catheter

  Class II

  FDA 510(k) K896448 Active Cleared 7 Mar 1990

• Laparoscopic Catherter

  Class II

  FDA 510(k) K903187 Active Cleared 12 Oct 1990

See all devices from Cook Ob/Gyn →

• What is the Female Continence Device intended to do?

  The Female Continence Device is designed to provide support to the pelvic organs to help manage urinary incontinence in females by maintaining anatomical positioning within the vaginal canal, as it is classified as a vaginal pessary under FDA nomenclature.

• Is the Female Continence Device sterile when shipped, and can it be sterilized before use?

  The device is not sterile at the time of shipment, but it may be sterilized prior to use as required by clinical protocols, allowing for flexibility in preparation based on institutional or procedural needs.

• Can the Female Continence Device be used more than once, or is it single-use only?

  The Female Continence Device is intended for either single-use or reusable applications in an obstetrics/gynecology setting, meaning its use depends on the clinical protocol and sterilization practices followed by the healthcare provider.

• What regulatory pathway was used for the Female Continence Device, and what is its classification?

  The device was cleared through the FDA 510(k) process under submission K883721 and is classified as a Class II medical device, with the product code HHW corresponding to a vaginal pessary.

• What clinical setting is the Female Continence Device designed for, and what specialty does it serve?

  The device is intended for use in obstetrics/gynecology settings and is specifically designed to support pelvic organ positioning in females to manage urinary incontinence, aligning with its classification under the Obstetrics/Gynecology medical specialty.