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Hx-5/6-1 Endoscopic Clipping Device

by Olympus America, Inc. 2 variants

510(k) K013066

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK013066 Date11 Dec 2001ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1418-2023 FDA Class II initiated 23 Feb 2023

    There have been complaints that the clip did not come out of the tube sheath during the procedure.

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  • Withdrawn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
MND
Device Class
Class II
Regulation
21 CFR Part 876.4400
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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