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
K990749Substantially Equivalent

Sof-Suction Fluid Evacuation System

X-Tech Medical Ltd, Danville CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990749 is the FDA 510(k) clearance record for SOF-SUCTION FLUID EVACUATION SYSTEM, a class II device, cleared for X-Tech Medical, LLC on under FDA product code HOZ (Sponge, Ophthalmic). FDA records list one 510(k) clearance for X-Tech Medical, LLC. As of , FDA records show no recalls naming K990749.

Clearance record

Decision date
Received
(25 days to decision)
Product code
HOZ Sponge, Ophthalmic
Regulation
21 CFR 886.4790
Device class
Class II
Review panel
Ophthalmic
Applicant
X-Tech Medical, LLC 111 Wild Oak Ct., Danville CA
510(k) summary
Summary
Third party review
No

Clearances, product code HOZ

Trailing 12 months

FDA records hold no clearances under product code HOZ in the trailing twelve months.

FDA records show no clearances under product code HOZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HOZ, 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 20260
October 20260