Unclaimed listing. This page was generated from public FDA data. The manufacturer hasn't claimed it yet.
Claim this listing →No product image
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
510(k) Status
Cleared
Active Recalls
None
Manufacturer
GEMSS HEALTHCARE CO., LTD.
Country of Origin
—
What it is
Specifications
No specifications on file yet. The manufacturer hasn't published spec data — claim this listing to add it.
Regulatory
FDA 510(k) Clearance
K233200
Cleared 2023-01-01 · Substantially Equivalent
Applicant: GEMSS HEALTHCARE CO., LTD.
Reference
Instructions for Use & Documents
No IFU or technique documents uploaded yet. Manufacturer can upload these after claiming the listing.
Learn
Education & How-to
No education content uploaded yet. Once claimed, manufacturers can upload procedure videos, technique guides, and training content.
Verified peers
Clinician Reviews
Reviews are open to NPI-verified clinicians. Be the first to share your experience with this device.
Sign in with NPI to review