XENON LIGHTSOURCE— 510(k) K962365

Name: FDA 510(k) clearance K962365
Creator: U.S. Food and Drug Administration
Published: 1996-07-18

Substantially Equivalent

Dsp Worldwide

FDA 510(k) clearance K962365 for XENON LIGHTSOURCE, Substantially Equivalent on 1996-07-18. Applicant: Dsp Worldwide. Device class: 2.

Clearance details

Applicant: Dsp Worldwide
Product code: Code GCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1996-06-19
Decision date: 1996-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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K962544 — MICRO DIAMOND-POINT DISSECTION NEEDLES1996-09-20
K962371 — DERMTOME BLADE1996-08-29

Adverse events under product code GCT

product code GCT

Malfunction: 1,393
Other: 2
Total: 1,395

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.