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SelectCore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093256

by Inrad

Identifiers

510(k) Number
K093256 FDA 510(k)
FDA Product Code
KNW FDA 510(k)
Models / Variants
991014 FDA 510(k)
991514 FDA 510(k)
991018 FDA 510(k)
991518 FDA 510(k)
992018 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1075 FDA 510(k)
Regulation Number
876.1075 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SelectCore Variable Throw Biopsy Device is a mechanically actuated biopsy instrument designed for soft tissue sampling. It features a variable throw mechanism, allowing precise adjustment of penetration depth between 15 and 25 millimeters, and incorporates a stainless steel cutting cannula and stylet housed in a plastic casing.

This device is supplied as a sterile, disposable instrument and is intended for single-use procedures. It is classified under product code KNW and has received FDA 510(k) clearance as substantially equivalent, with regulatory decision documentation dated November 17, 2009. The device is intended for use in controlled clinical settings, such as endoscopy or urology procedures, and requires proper storage to maintain sterility.

Frequently asked questions

What types of medical procedures is the SelectCore Variable Throw Biopsy Device designed for, and how does its variable throw mechanism benefit clinicians?

The SelectCore Variable Throw Biopsy Device is designed for soft tissue sampling in controlled clinical settings like endoscopy or urology procedures. Its variable throw mechanism allows clinicians to precisely adjust penetration depth between 15 and 25 millimeters, enabling tailored sampling based on tissue depth and anatomical location. This flexibility reduces the risk of incomplete or excessive sampling, improving procedural accuracy and patient safety.

Is the SelectCore Variable Throw Biopsy Device reusable, or is it intended for single-use? How should it be stored to maintain sterility?

The SelectCore Variable Throw Biopsy Device is sterile and disposable, intended for single-use only to ensure patient safety and infection control. To maintain sterility, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid opening the packaging until immediate use, and adhere to manufacturer guidelines for shelf-life and handling.

What materials is the SelectCore Variable Throw Biopsy Device made of, and how does this affect its durability or compatibility with imaging modalities?

The device features a stainless steel cutting cannula and stylet for precision and durability, housed in a plastic casing for ergonomic handling. The stainless steel components ensure structural integrity during use, while the plastic casing is designed for ease of manipulation. While the device is not explicitly described as MRI-compatible, the stainless steel components may pose risks in magnetic fields, so clinicians should verify compatibility with their specific imaging systems before use.

What are the key differences between the model variants (e.g., 991014 vs. 992018) of the SelectCore Variable Throw Biopsy Device?

The model variants (e.g., 991014, 991514, 991018, 991518, 992018) likely differ in cannula gauge or throw settings, though exact specifications are not detailed here. For example, the numerical differences (e.g.,

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SelectCore™ Biopsy Device - INRAD, Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018 ..., Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inrad

Sources (1)

  • FDA 510(k) K093256 24 fields · synced Sep 19, 2026