FUJINON EVL-F VIDEO LAPROSCOPE— 510(k) K983561

Name: FDA 510(k) clearance K983561
Creator: U.S. Food and Drug Administration
Published: 1998-12-16

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K983561 for FUJINON EVL-F VIDEO LAPROSCOPE, Substantially Equivalent on 1998-12-16. Applicant: Fujinon, Inc.. Device class: 2.

Clearance details

Applicant: Fujinon, Inc.
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1998-10-13
Decision date: 1998-12-16
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCJ

view all

K263459 — SWICS2026-10-29
K262455 — da Vinci 5 Handheld Camera Head (470080) +4 more2026-10-14
K262397 — CuratOR EX27422026-09-11
K260884 — UNIDRIVE Select System2026-09-01
K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor2026-08-26

More clearances from Fujinon, Inc.

view all

K120446 — FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT22012-08-13
K112391 — FUJINON COLONOSCOPES2012-07-26
K102466 — FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR2011-05-25
K111243 — FUJINON ULTRASONIC PROCESSOR2011-05-16
K091773 — FUJINON STERILE OVERTUBES2009-08-07

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.