DeviceClearance

Product code FAJ— Gastroenterology, Urology

Flexible HD Cysto-Urethroscope System

Classification name
Cystoscope And Accessories, Flexible/Rigid
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
92
First cleared
Most recent

FDA classification definition

“To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

— U.S. Food and Drug Administration, device classification record for product code FAJ under 21 CFR 876.1500, via openFDA

Market context for product code FAJ

FDA has cleared 92 devices under product code FAJ between 1976 and 2026, filed by 61 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FAJ

Adverse events under product code FAJ

product code FAJ
Injury
533
Malfunction
6,705
Total
7,238

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 →

Recent clearances under product code FAJ

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