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SureClip Implantable Clip

by Conmed Corporation

510(k) K150936

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150936↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK150936 Date23 Oct 2015ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Full name
SureClip
510(k) Number
FDA product code
FZP
Device class
Class II
Regulation
21 CFR Part 878.4300
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

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 SureClip Implantable Clip is a surgical device classified as an implantable clip, designed for securing tissue during procedures. It is intended for use in general and plastic surgery applications, providing a reliable method for approximating and maintaining tissue edges in a closed position.

The device is supplied as a reusable, non-sterile item and is intended for single-use per patient. It is not MRI-safe and must be handled with care to avoid contamination. The SureClip is authorised under FDA 510K and MDD regulations, adhering to the classification under device code FZP and regulation number 878.4300. Multiple registration numbers are associated with its various configurations and sizes.

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