510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072594Substantially Equivalent

Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System

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

K072594 is the FDA 510(k) clearance record for GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM, a class II device, cleared for Gyrus Acmi, Inc. on under FDA product code FGA (Kit, Nephroscope). FDA records list 67 510(k) clearances for Gyrus Acmi, Inc., from to . As of , FDA records show no recalls naming K072594.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FGA Kit, Nephroscope
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 FGA

Trailing 12 months

FDA records hold no clearances under product code FGA in the trailing twelve months.

FDA records show no clearances under product code FGA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260