510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K890218Substantially Equivalent

Microsurgical Cystotome

Kinetic Medical Products, Erie PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890218 is the FDA 510(k) clearance record for MICROSURGICAL CYSTOTOME, a class I device, cleared for Kinetic Medical Products on under FDA product code KOA (Surgical Instruments, G-U, Manual (And Accessories)). FDA records list 63 510(k) clearances for Kinetic Medical Products, from to . As of , FDA records show no recalls naming K890218.

Clearance record

Decision date
Received
(9 days to decision)
Product code
KOA Surgical Instruments, G-U, Manual (And Accessories)
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Kinetic Medical Products 4934 Peach St., Erie PA
Third party review
No

Clearances, product code KOA

Trailing 12 months

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

FDA records show no clearances under product code KOA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KOA, 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