inforMED
FAJClass II

Cystoscope And Accessories, Flexible/rigid

Gastroenterology, Urology · 21 CFR 876.1500

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).

MDR events10,640All time
Recalls22All time
Registered firms273Currently listed
510(k) clearances92All time

Product problems

Reported product problem codes, most common first

Detachment of Device or Device Component2,980
Failure to Clean Adequately960
Device Reprocessing Problem776
Corroded730
Loss of or Failure to Bond707
Break695
Microbial Contamination of Device565
No Display/Image410

Trend for “Detachment of Device or Device Component

0250500Aug 23Feb 24Aug 24Feb 25Aug 25Feb 26

Recalls

22 recall events for this product code

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510(k) clearances

92 clearances for this product code

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