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Clip HX-610-135

by Olympus Medical Systems Corporation

Clip HX-610-135 (N1085630) is a Class II device made by Olympus Medical Systems Corporation, cleared under FDA 510(k) K240617 on 3 Jun 2024 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170200311), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K240617

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240617 Date3 Jun 2024DecidedStatusActive
United StatesGUDID listing Number04953170200311 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240617 decided 3 Jun 2024 Active
  • FDA GUDID UDI-DI 04953170200311 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04953170200311
  2. Cleared FDA 510(k) K240617

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Clip
Generic name
Ligation clip, metallic
Model / Ref / Catalog
HX-610-135, N1085630
Primary DI / UDI-DI
04953170200311
510(k) Number
FDA product code
PKL
GMDN term
Ligation clip, metallic
Device class
Class II
Regulation number
876.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ligation clip, metallic

Cleared under the same submission (K240617)

and 8 more cleared under K240617

Similar devices in this category

Other devices filed under Ligation clip, metallic.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)