ArthoCare Ablation Wand, Reprocessed
by Renovo, Inc.
510(k) K173741
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173741 | Date5 Mar 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Reprocessed ArthoCare Ablation Wand
- 510(k) Number
- FDA Product Code
- NUJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ArthoCare Ablation Wand, Reprocessed, is classified as an Electrosurgical, Cutting & Coagulation Accessory designed for laparoscopic and endoscopic procedures. This device is intended for tissue ablation, coagulation, or cutting during minimally invasive surgeries, leveraging electrosurgical principles to achieve precise control over tissue effects. It is part of a reprocessed category, meaning it undergoes cleaning, disinfection, and sterilization to ensure safety for repeated use in clinical settings.
This device is supplied as a reprocessed single-use accessory, adhering to FDA regulations under 21 CFR 878.4400 and classified as a Class II medical device. It is intended for use in sterile environments, such as operating rooms or procedural suites, and must be handled according to reprocessing protocols to maintain sterility and functionality. The device received FDA 510(k) clearance (K173741) under the Substantially Equivalent (SESE) determination, affirming its compliance with regulatory standards for reprocessed electrosurgical accessories.
Other devices from Renovo, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Reprocessed ArthoCare Ablation Wand used for?
The Reprocessed ArthoCare Ablation Wand is designed for laparoscopic and endoscopic surgeries, where it provides controlled tissue ablation, coagulation, or cutting. Its electrosurgical function allows clinicians to achieve precise tissue effects during minimally invasive procedures, reducing trauma and improving procedural outcomes.
How is the Reprocessed ArthoCare Ablation Wand supplied and prepared for use?
This device is supplied as a reprocessed single-use accessory, meaning it undergoes rigorous cleaning, disinfection, and sterilization to ensure safety for repeated clinical use. It must be handled according to reprocessing protocols to maintain sterility and functionality, adhering to FDA regulations under 21 CFR 878.4400.
Is the Reprocessed ArthoCare Ablation Wand intended for reuse, and if so, how?
Yes, the device is intended for reuse after reprocessing. It is classified as a reprocessed single-use accessory, meaning it is cleaned, disinfected, and sterilized by the manufacturer or a certified reprocessing facility before being returned to clinical use. This ensures compliance with regulatory standards for safety and sterility in sterile environments like operating rooms.
What regulatory approval does the Reprocessed ArthoCare Ablation Wand hold?
The device received FDA 510(k) clearance under the Substantially Equivalent (SESE) determination, confirming its compliance with regulatory standards for reprocessed electrosurgical accessories. This clearance was granted following a review by the FDA’s General and Plastic Surgery Advisory Committee.
Where and how should the Reprocessed ArthoCare Ablation Wand be stored?
The device must be stored in a sterile environment, such as an operating room or procedural suite, following reprocessing protocols to preserve sterility and functionality. Proper storage ensures it remains ready for use while maintaining the integrity of its electrosurgical components.