Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)
by Kirwan Surgical Products LLC
510(k) K231872
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK231872 | Date25 Aug 2023 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Models / Variants
- FDA applicant
- Kirwan Surgical Products, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Polaris system is a modular electrosurgical generator suite designed for bipolar coagulation and irrigation during surgical procedures. It combines a bipolar electrosurgical generator (29-1000) with optional irrigation (29-1600) and light source (29-1900) modules, enabling precise tissue control and enhanced visibility in operating environments.
The system is supplied as a reusable medical device, featuring a dual footswitch (29-1020) for operator control. It is intended for use in surgical settings, with regulatory clearance under FDA 510K (K231872) and compliance with the Medical Devices Directive (MDD). The modular components are designed for integration within general and plastic surgery procedures, adhering to established safety and performance standards.
Other devices from Kirwan Surgical Products LLC
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures is the Polaris system primarily designed for, and how does it enhance the surgical experience?
The Polaris system is designed for use in general and plastic surgery procedures. It combines bipolar coagulation and optional irrigation and lighting modules to provide precise tissue control and improved visibility during surgery. The modular design allows clinicians to customize the system for specific needs, ensuring better surgical outcomes in controlled environments.
Is the Polaris system reusable, and if so, what does this mean for maintenance and longevity?
Yes, the Polaris system is supplied as a reusable medical device. This means it is built for repeated use in clinical settings, requiring proper cleaning, sterilization, and maintenance as per manufacturer guidelines to ensure safety, performance, and longevity. Reusability also supports cost efficiency for healthcare facilities.
How does the modular design of the Polaris system benefit surgeons during an operation?
The modular design allows surgeons to integrate only the components they need—such as the bipolar electrosurgical generator (29-1000), irrigation module (29-1600), or light source module (29-1900)—into their workflow. This flexibility ensures optimal functionality for specific procedures, reducing clutter and improving efficiency while maintaining precise control over coagulation and visibility.
What regulatory pathways does the Polaris system follow, and how does this affect its use in clinical settings?
The Polaris system has received FDA clearance under the 510(k) pathway (K231872) and complies with the Medical Devices Directive (MDD). This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device, ensuring it meets established safety and performance standards for use in surgical settings. Clinicians can rely on its regulatory compliance for trusted performance.
Can you explain the role of the dual footswitch (29-1020) in the Polaris system and how it improves surgical workflow?
The dual footswitch (29-1020) provides hands-free control for the surgeon, allowing precise activation of the bipolar electrosurgical generator without interrupting the procedure. This ergonomic feature enhances efficiency by enabling seamless transitions between coagulation and other functions, reducing fatigue and improving focus during surgery.