510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K945210Substantially Equivalent

Ksea Disposable Tubing Set for the Uromat Pump

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

K945210 is the FDA 510(k) clearance record for KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code LJH (System, Irrigation, Urological). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K945210.

Clearance record

Decision date
Received
(105 days to decision)
Product code
LJH System, Irrigation, Urological
Regulation
21 CFR 876.5130
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 LJH

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