510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K003569Substantially Equivalent

Plasmakinetic Endourology System

Gyrus ACMI, Inc., Cardiff, Wales, GB / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K003569 is the FDA 510(k) clearance record for PLASMAKINETIC ENDOUROLOGY SYSTEM, a class II device, cleared for Gyrus Medical , Ltd. on under FDA product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)). FDA records list 67 510(k) clearances for GYRUS ACMI, INC., from to . As of , FDA records show no recalls naming K003569.

Clearance record

Decision date
Received
(29 days to decision)
Product code
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gyrus Medical , Ltd. Fortran Rd., St. Mellons, Cardiff, Wales, GB
510(k) summary
Summary
Third party review
No

Clearances, product code KNS

Trailing 12 months
2 clearances under product code KNS in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260