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Achieve Programmable Auomated Biopsy Systems

by Care Fusion

510(k) K141552

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 NumberK141552 Date5 Sep 2014ClearedStatusActive

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  • Withdrawn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
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
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 Achieve Programmable Automated Biopsy System is a spring-loaded, automated device designed for soft tissue biopsy procedures. It provides precise control and consistent sampling depth, facilitating accurate tissue acquisition from calcified or fibrous lesions. This system is classified under the product code KNW and is intended for use in interventional radiology and endoscopy settings.

The device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K141552) with a decision date of September 5, 2014. It was reviewed by the Gastroenterology and Urology Advisory Committee and is intended for single-use applications per standard clinical practice. Storage and handling follow general medical device protocols to maintain sterility and functionality.

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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 Achieve Programmable Automated Biopsy System used for?

    The Achieve Programmable Automated Biopsy System is designed for soft tissue biopsy procedures, particularly in interventional radiology and endoscopy. Its spring-loaded mechanism provides precise control and consistent sampling depth, making it ideal for acquiring tissue samples from calcified or fibrous lesions where accuracy is critical.

  • Is the Achieve Automated Biopsy System reusable or single-use?

    The device is classified as a reusable medical instrument, though it is intended for single-use applications in standard clinical practice. This aligns with typical protocols for maintaining sterility and functionality, ensuring each use remains safe and effective.

  • How should the Achieve Automated Biopsy System be stored?

    Storage and handling of the Achieve Automated Biopsy System follow general medical device protocols to preserve sterility and functionality. Specific instructions should be followed to ensure the device remains in optimal condition for its intended use, particularly if reused in accordance with clinical guidelines.

  • What regulatory approval does the Achieve Automated Biopsy System hold?

    The device holds FDA 510(k) clearance under the reference number K141552, with a decision date of September 5, 2014. It was reviewed by the Gastroenterology and Urology Advisory Committee and classified under product code KNW, indicating its intended use in specialized medical procedures.

  • Can this device be used for both radiology and endoscopy?

    Yes, the Achieve Programmable Automated Biopsy System is explicitly intended for use in both interventional radiology and endoscopy settings. Its design supports precise tissue sampling in these diverse clinical environments, ensuring versatility for different procedural needs.