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
K972664Substantially Equivalent

Storz Millennium Viscous Fluid System

Storz Instrument Co., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972664 is the FDA 510(k) clearance record for STORZ MILLENNIUM VISCOUS FLUID SYSTEM, a class II device, cleared for Storz Instrument Co. on under FDA product code MRH (Pump, Infusion, Ophthalmic). FDA records list 101 510(k) clearances for Storz Instrument Co., from to . As of , FDA records show no recalls naming K972664.

Clearance record

Decision date
Received
(86 days to decision)
Product code
MRH Pump, Infusion, Ophthalmic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Storz Instrument Co. 3365 Tree Ct. Industrial Blvd., St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code MRH

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