510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221690Substantially Equivalent

Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R), Light Guide Adapter (Maj-1413)

Olympus Medical Systems Corp., Hachioji-Shi, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221690 is the FDA 510(k) clearance record for OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413), a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid). FDA's definition for product code FAJ reads: "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...". FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show 3 recalls naming K221690.

Clearance record

Decision date
Received
(202 days to decision)
Product code
FAJ Cystoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FAJ

Trailing 12 months
5 clearances under product code FAJ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FAJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20262
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260