FUJINON STERILE OVERTUBES— 510(k) K091773

Name: FDA 510(k) clearance K091773
Creator: U.S. Food and Drug Administration
Published: 2009-08-07

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K091773 for FUJINON STERILE OVERTUBES, Substantially Equivalent on 2009-08-07. Applicant: Fujinon, Inc.. Device class: 2.

Clearance details

Applicant: Fujinon, Inc.
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-06-16
Decision date: 2009-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FED

view all

K260410 — Single Use Ureteral Access Sheath2026-09-11
K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
K260965 — CVAC Aspiration System2026-04-13
K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)2026-04-06
K252572 — Prodeon Urethral Sheath System2025-10-07

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
K090116 — FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B152009-04-22

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.