Identifiers
- 510(k) Number
- K142816 FDA 510(k)
- FDA Product Code
- KNT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AbbVie J is a ureteral access sheath (product code KNT), a tubular device designed to facilitate the insertion and manipulation of ureteroscopes within the ureter for diagnostic and therapeutic procedures. It provides a protected pathway for instruments, reducing trauma to the ureteral walls while enabling clearer visualization and improved access during interventions such as stone removal or biopsy.
Supplied as a single-use device, the AbbVie J is intended for use in urological settings, including operating rooms and endoscopy suites. It is cleared by the FDA under 510K (K142816) as substantially equivalent to a predicate device, with no third-party involvement. Sterility and sizing details are not specified in the submission data, but compliance with 510K clearance ensures adherence to regulatory standards for ureteral sheaths in urological procedures.
Frequently asked questions
What is the primary purpose of the AbbVie J ureteral access sheath in clinical procedures?
The AbbVie J is designed to create a protected pathway within the ureter for ureteroscopes, reducing friction and trauma to the ureteral walls during diagnostic or therapeutic interventions. This allows for clearer visualization and easier manipulation of instruments, making it particularly useful for procedures like stone removal or biopsy.
Is the AbbVie J intended for reuse or is it meant to be used only once?
The AbbVie J is explicitly labeled as a single-use device, meaning it should not be reused after a single procedure. This classification aligns with standard practices for ureteral access sheaths to ensure patient safety and sterility.
How is the AbbVie J regulated, and what does its FDA clearance status mean for clinicians?
The AbbVie J received FDA clearance under a 510(k) submission (K142816), determined to be substantially equivalent to a predicate device. This means it meets regulatory standards for ureteral access sheaths and is approved for use in urological procedures like those in operating rooms or endoscopy suites, though specific sterility or sizing details are not detailed in the submission.
What types of clinical settings is the AbbVie J intended for, and why?
The AbbVie J is intended for urological settings, including operating rooms and endoscopy suites, as it facilitates minimally invasive procedures requiring precise ureteral access. Its design supports interventions where reducing ureteral trauma and improving instrument maneuverability are critical, such as during stone extraction or tissue sampling.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142816 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbvie Inc.
- FDA Applicant
- AbbVie , Inc.
Sources (1)
- FDA 510(k) K142816 24 fields · synced Sep 20, 2026