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Hemedex Fixation Device

by Hemedex Incorporated

510(k) K032127

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK032127 Date30 Dec 2003ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNY
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Hemedex Fixation Device is a medical accessory classified under Accessories, Catheter, Gastroenterology, Urology (FDA Product Code: KNY). It is designed to secure percutaneous devices to the patient’s skin, ensuring stable placement and minimizing displacement risk during use. This device is intended for use with compatible catheters or probes, such as the QFlow Perfusion Probe, to maintain proper positioning during medical procedures.

The device is supplied as a reusable medical accessory and is intended for single-patient use per application. It is not sterile at time of shipment but may be sterilized prior to use as required by clinical protocols. The Hemedex Fixation Device is regulated under FDA 510(k) clearance (K032127) and falls under Class II medical device classification. Compliance with 21 CFR 876.5130 applies, and it is intended for use in urological and gastroenterological settings.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Hemedex Fixation Device used for?

    The Hemedex Fixation Device is designed to secure percutaneous catheters or probes, such as the QFlow Perfusion Probe, to a patient’s skin. This ensures stable placement during medical procedures in urology and gastroenterology, minimizing the risk of displacement which could compromise treatment accuracy or patient safety.

  • Is the Hemedex Fixation Device reusable or single-use?

    The Hemedex Fixation Device is classified as a reusable medical accessory. However, it is intended for single-patient use per application, meaning it should not be reused on another patient without proper sterilization and clinical protocol adherence.

  • Is the Hemedex Fixation Device sterile when shipped?

    No, the Hemedex Fixation Device is not sterile at the time of shipment. It can be sterilized prior to use according to established clinical protocols to ensure safety and efficacy during procedures.

  • What types of procedures is the Hemedex Fixation Device intended for?

    The device is intended for use in urological and gastroenterological settings, specifically to secure catheters or probes during percutaneous procedures where stable positioning is critical.

  • What regulatory pathway does the Hemedex Fixation Device follow?

    The Hemedex Fixation Device is regulated under the FDA 510(k) clearance pathway (K032127) and falls under Class II medical device classification. It complies with 21 CFR 876.5130, which governs accessories for catheters in gastroenterology and urology.