Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (2
Summary
Kirwan Surgical Products, LLC received 510(k) clearance for Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020), a GEI device. Cleared on 2023-08-25.
Details
Source
510(k) Clearance
External ID
K231872
Action Date
2023-08-25
Status
Traditional
Category
device
Product Code
GEI
Product Description
Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020). Product code: GEI.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Kirwan Surgical Products, LLC has 8 FDA actions in our database, including 7 recalls and 1 clearance.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Kirwan Surgical Products, LLC have FDA actions?
Kirwan Surgical Products, LLC has 8 FDA actions in our database, including 7 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231872" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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