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Single Use Reloadable Clip Applicator - Short Clip (HX-610-090S, HX-610-135S)

by Olympus Medical Systems Corp.

510(k) K240617

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 NumberK240617 Date3 Jun 2024ClearedStatusActive

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  • Withdrawn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
PKL
Models / Variants
Short Clip (HX-610-090S, HX-610-135S)
Device Class
Class II
Regulation
21 CFR Part 876.4400
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) and associated clips (HX-610-090, HX-610-135, HX-610-090L, HX-610-135L, HX-610-090S, HX-610-135S, HX-610-135XS) are a hemostatic metal clip system for the gastrointestinal tract. This device is designed for endoscopic clip placement within the gastrointestinal (GI) tract in adult patients.

The system is intended for endoscopic marking and hemostasis of mucosal and sub-mucosal defects. The applicator handle is reloadable and designed for use with an Olympus endoscope. The device is authorized via FDA 510(k) clearance.

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