510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K905553Substantially Equivalent

Lithotriptor System Model 27080

Karl Storz GmbH & Co. (Kst), Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905553 is the FDA 510(k) clearance record for LITHOTRIPTOR SYSTEM MODEL 27080, a class II device, cleared for Karl Storz GmbH & Co. (Kst) on under FDA product code FFK (Lithotriptor, Electro-Hydraulic). FDA records list one 510(k) clearance for Karl Storz GmbH & Co. (Kst). As of , FDA records show no recalls naming K905553.

Clearance record

Decision date
Received
(175 days to decision)
Product code
FFK Lithotriptor, Electro-Hydraulic
Regulation
21 CFR 876.4480
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Karl Storz GmbH & Co. (Kst) 10111 W. Jefferson Blvd., Culver City CA
Third party review
No

Clearances, product code FFK

Trailing 12 months

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

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