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Heli-Tech Retrieval Basket

by Cape Tech Medical Products

510(k) K926040

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK926040 Date23 Dec 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LQR
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Heli-Tech Retrieval Basket is a Dislodger, Stone, Biliary (FDA classification 876.5010), designed for the retrieval of biliary stones or other foreign bodies during endoscopic procedures. Its helical design facilitates secure grasping and extraction of stones or debris from the biliary tract or gallbladder without causing additional trauma to surrounding tissues.

This device is intended for single-use in clinical settings such as gastroenterology and urology. Supplied sterile, it is classified as a Class II medical device under FDA regulations and holds a FDA 510(k) clearance (K926040) with a product code of LQR. No third-party review was required, and it is not MRI-compatible. Storage and handling must comply with standard sterile instrument protocols.

Other devices from Cape Tech Medical Products

Questions

AI-generated answers, 19 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 clinical specialties is the Heli-Tech Retrieval Basket primarily used in, and why is it designed this way?

    The Heli-Tech Retrieval Basket is primarily used in gastroenterology and urology procedures, as indicated by its FDA classification (Dislodger, Stone, Biliary) and advisory committee designation. Its helical design is optimized for securely grasping and extracting biliary stones or foreign bodies from the biliary tract or gallbladder during endoscopic interventions, minimizing trauma to surrounding tissues—a critical consideration in these specialties.

  • Is the Heli-Tech Retrieval Basket reusable, or is it intended for single-use only? How does this affect its handling?

    The Heli-Tech Retrieval Basket is intended for single-use only, as explicitly stated in its description. This design choice ensures sterility and reduces the risk of cross-contamination between patients. As it is supplied sterile, proper adherence to standard sterile instrument protocols is required during storage and handling to maintain its integrity for one-time clinical use.

  • What sizes or models of the Heli-Tech Retrieval Basket are available, and how might this affect its application?

    The provided data does not specify individual sizes or model variants of the Heli-Tech Retrieval Basket, but its helical design suggests versatility for different stone sizes within the biliary tract. Clinicians should refer to the manufacturer’s packaging or instructions for specific dimensions or model distinctions. The lack of explicit size details implies a standardized approach for general biliary stone retrieval, though compatibility with various endoscopic tools may vary.

  • How should the Heli-Tech Retrieval Basket be stored, and what precautions should be taken given its sterile and single-use nature?

    The Heli-Tech Retrieval Basket must be stored according to standard sterile instrument protocols, as it is supplied sterile and intended for single-use. This includes protecting it from contamination, moisture, and physical damage. Storage conditions should align with manufacturer guidelines to preserve sterility until use, ensuring it remains safe and effective for its intended clinical application without compromise.

  • Is the Heli-Tech Retrieval Basket compatible with MRI machines, and what does this mean for its use in imaging-dependent procedures?

    The Heli-Tech Retrieval Basket is not MRI-compatible, as explicitly noted in the device description. This means it should not be used in procedures involving MRI imaging, as exposure to magnetic fields could pose risks to the device or the patient. Clinicians should confirm compatibility with imaging modalities before use, particularly in hybrid or diagnostic settings where MRI may be involved.