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Zone Specific AIM

by Conmed Corporation

510(k) K220186

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220186↗

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 NumberK220186 Date13 May 2022ClearedStatusActive
European UnionCE/MDR 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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GAT
Device Class
Class II
Regulation
21 CFR Part 878.5000
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 Zone Specific AIM is a Surgical Stapling Device designed for tissue approximation and ligation in soft tissues. It employs a zone-specific approach to apply staples with precise control, ensuring secure closure of surgical incisions while minimising tissue trauma.

This device is intended for single-use in surgical settings and is supplied sterile. It is classified under the General, Plastic Surgery advisory committee category and has received FDA 510K clearance under the Traditional pathway. Compliance with MDR requirements is also noted, ensuring adherence to regulatory standards for medical devices.

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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.

  • What types of surgical procedures is the Zone Specific AIM designed for, and how does its zone-specific stapling help reduce tissue trauma?

    The Zone Specific AIM is designed for soft tissue approximation and ligation during surgical procedures in general and plastic surgery settings. Its zone-specific stapling technology applies precise control over staple placement, which helps tailor the closure to the specific tissue characteristics of different anatomical zones. This targeted approach minimizes unnecessary tissue compression or damage, reducing trauma while ensuring a secure incision closure.

  • Is the Zone Specific AIM intended for reuse, or is it meant to be used only once? How does this affect its clinical use?

    The Zone Specific AIM is explicitly designed for single-use only in surgical settings. This design choice ensures sterility and safety for each patient, eliminating the risk of cross-contamination or degradation of performance from repeated use. Clinicians should follow the manufacturer’s instructions for single-patient use and proper disposal after use.

  • How is the Zone Specific AIM supplied, and what should clinicians check before using it in an operating room?

    The Zone Specific AIM is supplied sterile and ready for immediate use in surgical settings. Clinicians should verify the sterility indicators (e.g., packaging seals or labels) before opening the device. Since it is single-use, it should not be reused or resterilized, and any unused portions must be discarded according to facility protocols.

  • What regulatory pathways does the Zone Specific AIM follow, and how does this impact its availability in different markets?

    The Zone Specific AIM has received FDA 510(k) clearance under the Traditional pathway, confirming it is deemed substantially equivalent to a legally marketed predicate device. It also complies with MDR (Medical Device Regulation) requirements, ensuring it meets EU regulatory standards. This dual clearance supports its availability in both the U.S. and European markets, though clinicians should confirm local compliance and distribution channels.