510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K980808Substantially Equivalent

Endo Fms Urology

Future Medical Systems, Inc., Glen Burnie MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980808 is the FDA 510(k) clearance record for ENDO FMS UROLOGY, a class II device, cleared for Future Medical Systems, Inc. on under FDA product code LJH (System, Irrigation, Urological). FDA records list 14 510(k) clearances for Future Medical Systems, Inc., from to . As of , FDA records show no recalls naming K980808.

Clearance record

Decision date
Received
(66 days to decision)
Product code
LJH System, Irrigation, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Future Medical Systems, Inc. 504 Mccormick Dr., Glen Burnie MD
510(k) summary
Statement
Third party review
No

Clearances, product code LJH

Trailing 12 months
1 clearance under product code LJH in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJH, 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 20261
October 20260