Cervicath

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K881414 ↗

FDA Product Code

HDR

Device Class

Class II

Regulation

21 CFR Part 884.5250

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Urostresstik Diagnostic Cystometry Pack

  Class II

  FDA 510(k) K844503 Active Cleared 2 Jan 1985

• Epcom Ems-310 Intrapartum Monitor

  Class II

  FDA 510(k) K831113 Active Cleared 12 Aug 1983

• Glove-N-Gel Amniotomy Kit

  Class I

  FDA 510(k) K910518 Active Cleared 9 May 1991

• Epcom Ems-180 Antepartum Fetal Monitor

  Class II

  FDA 510(k) K813007 Active Cleared 10 Dec 1981

• Intrauterine Catheter Set

  Class II

  FDA 510(k) K905812 Active Cleared 31 Jan 1991

• Epcom Ems-330 Freedom I Teledop Obstet

  Class II

  FDA 510(k) K831114 Active Cleared 12 Aug 1983

See all devices from Epcom Medical Systems, Inc. →

• What is CERVICATH used for?

  CERVICATH is a cervical cap device used in obstetrics and gynecology as a barrier contraceptive. It is designed to fit over the cervix to prevent sperm from entering the uterus, providing a non-hormonal method of birth control.

• Is CERVICATH sterile or non-sterile when supplied?

  CERVICATH is supplied non-sterile, as indicated in the device data. This means it is not provided in a sterile condition and requires appropriate cleaning or preparation by the user before each use according to manufacturer instructions.

• Can CERVICATH be reused, or is it single-use?

  CERVICATH is intended for reusable use, as explicitly stated in the device description. It is designed to be cleaned and used multiple times, making it a reusable barrier contraceptive rather than a disposable device.

• What regulatory pathway was used for CERVICATH?

  CERVICATH received FDA 510(k) clearance under submission K881414, which is noted in the AUTHORIZATIONS field. This traditional 510(k) pathway determined the device to be substantially equivalent to a legally marketed predicate device.