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
K882295Substantially Equivalent

Filling Volume Option

Eris Medical Technology, New Providence NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882295 is the FDA 510(k) clearance record for FILLING VOLUME OPTION, a class II device, cleared for Eris Medical Technology on under FDA product code LJH (System, Irrigation, Urological). FDA records list 3 510(k) clearances for Eris Medical Technology, from to . As of , FDA records show no recalls naming K882295.

Clearance record

Decision date
Received
(103 days to decision)
Product code
LJH System, Irrigation, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Eris Medical Technology 1308 Springfield Ave., New Providence NJ
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