510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090814Substantially Equivalent

Modification to Gyrus Acmi Invisio Icn, Models Icn-0564 and Icn-0565

Gyrus ACMI, Inc., Southborough MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090814 is the FDA 510(k) clearance record for MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565, a class II device, cleared for Gyrus Acmi, Inc. 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 67 510(k) clearances for Gyrus Acmi, Inc., from to . As of , FDA records show no recalls naming K090814.

Clearance record

Decision date
Received
(26 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
Gyrus Acmi, Inc. 136 Tpke. Rd., Southborough MA
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