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Female IC (Not Finalized)

by Hollister Incorporated

510(k) K213575

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213575 Date13 Sep 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EZD
Device class
Class II
Regulation
21 CFR Part 876.5130
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a straight catheter classified under the urological catheter and accessories category. It is intended for use in gastroenterology and urology applications.

The device is supplied as a Class II medical device with FDA 510(k) clearance under product code EZD and regulation number 21 CFR§ 876.5130. It was cleared via the traditional 510(k) pathway and is manufactured by Hollister Incorporated.

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