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Utage-Matsu-Micro-Thin Utage-Sakura

by Kopharm, Inc. 510(k)

Active United States

510(k) K800518

Overview

This device is a condom, as defined by its device name and classification. It is a barrier contraceptive intended for use in obstetrics and gynecology settings.

It was cleared via the FDA 510(k) process under K800518, granted on March 20, 1980, and is classified as a Class II medical device. The product is supplied non-sterile and is intended for single-use.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800518 Date20 Mar 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA used for?

    The UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA is a barrier contraceptive intended for use in obstetrics and gynecology settings.

  • Is the UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA supplied sterile?

    No, the UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA is supplied non-sterile.

  • Can the UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA be reused?

    No, the UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA is intended for single-use.