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DetachaTip III Plus Instrument Tray Model 3-4343

by Conmed Corporation

510(k) K123175

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

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) K123175↗

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 · Abbreviated NumberK123175 Date21 Feb 2013ClearedStatusActive
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  • Withdrawn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)

510(k) Number
FDA Product Code
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
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 DetachaTip III Plus Instrument Tray Model 3-4343 is a reusable surgical instrument tray designed for the storage and organisation of DetachaTip III shafts and handles, as well as other multi-use ConMed devices. It is classified as a surgical instrument tray under the product code KCT, intended for use in general hospital settings.

This tray is structured with a deeper design than standard models, featuring a top compartment for DetachaTip III shafts and handles and a bottom section for additional reusable instruments. Supplied as a reusable device, it requires sterilisation between uses and is authorised under FDA 510K clearance and MDD compliance. The tray is intended for hospital environments and must be stored and handled according to standard surgical instrument protocols.

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Questions

AI-generated answers, 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.

  • Is this instrument tray designed for single-use or can it be reused after proper sterilization?

    This tray is explicitly labeled as a reusable device. Since it is intended for surgical use in hospital settings, it must undergo sterilization between each use to maintain safety and compliance with surgical instrument protocols. Always follow standard sterilization procedures for reusable medical devices.

  • What types of instruments does this tray organize, and how is it structured?

    The DetachaTip III Plus Instrument Tray Model 3-4343 is designed to organize DetachaTip III shafts and handles, as well as other reusable ConMed surgical instruments. It features a two-compartment design: a top section for the DetachaTip III components and a deeper bottom section for additional reusable instruments, providing better storage and organization compared to standard trays.

  • Where is this device authorized for use, and what regulatory pathways does it follow?

    This tray is authorized for use in general hospital settings and follows two regulatory pathways: it holds FDA 510(k) clearance (under K123175) and complies with the Medical Device Directive (MDD). The clearance was granted through an abbreviated review by the Orthopaedics (HO) Advisory Committee, confirming its substantial equivalence to a previously cleared device.

  • How should this tray be stored to ensure proper functionality and longevity?

    Since this is a reusable surgical instrument tray, it must be stored in a clean, dry environment following standard surgical instrument protocols. Avoid exposure to moisture, extreme temperatures, or physical damage, as these can compromise its structural integrity or sterilization readiness. Always adhere to hospital guidelines for instrument storage and maintenance.