DeviceClearance

ACCU-BEAM 300W XENON LIGHT SOURCE— 510(k) K951895

Substantially Equivalent

Tti Medical

FDA 510(k) clearance K951895 for ACCU-BEAM 300W XENON LIGHT SOURCE, Substantially Equivalent on 1995-05-24. Applicant: Tti Medical.

Clearance details

Applicant
Tti Medical
Product code
Code GCT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasanton, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GCT

product code GCT
Malfunction
1,393
Other
2
Total
1,395

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.