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SOLID CLIP™ Single Use Clip Applier

by Medscope Biotech Co., Ltd.

510(k) K221495Ref CA169, CA166, CA168Model CA165, CA166, CA167, CA168, CA169, CA567, CA568

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221495↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number47198769901Y4 Basic UDI-DI Date15 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK221495 Date18 Jul 2024ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Trade Name
Solid Clip
Model / Reference
CA165, CA166, CA167, CA168, CA169, CA567, CA568
Primary DI / UDI-DI
04719876990099, 04719876990051, 04719876990013
Basic UDI-DI
47198769901Y4
510(k) Number
FDA Product Code
FZP
EMDN Code
H03020101 Single-use multiple clip appliers for videosurgery
Device Class
Class IIb EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4300
EU market of registration
Greece
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIb
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

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

The Solid Clip Single Use Clip Applier is a disposable, single-use surgical instrument designed for ligating tissue during minimally invasive procedures. It applies clips to occlude vessels or ducts, reducing bleeding and facilitating precise surgical control in plastic and general surgery applications.

This device is supplied as a sterile, single-use instrument in a pre-packaged format, featuring a 10mm clip size and a jaw shaft rotation knob for stable clip application. It is intended for use in sterile surgical environments and adheres to FDA 510(k) and MDR regulatory standards. The CA16 Series is classified as a Class II medical device under FDA regulations.

Other devices from Medscope Biotech Co., Ltd.

Properties

  • Sterile
  • Implantable
  • Sutures

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No