510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K981233Substantially Equivalent

Ksea Calcusplit

Karl Storz Endoscopy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981233 is the FDA 510(k) clearance record for KSEA CALCUSPLIT, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code FFK (Lithotriptor, Electro-Hydraulic). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K981233.

Clearance record

Decision date
Received
(73 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 Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260