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
K935123Substantially Equivalent

Superstand 300

Wuestec Medical, Inc., Mobile AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935123 is the FDA 510(k) clearance record for SUPERSTAND 300, a class I device, cleared for Wuestec Medical, Inc. on under FDA product code IYB (Tube Mount, X-Ray, Diagnostic). FDA records list 9 510(k) clearances for Wuestec Medical, Inc., from to . As of , FDA records show no recalls naming K935123.

Clearance record

Decision date
Received
(881 days to decision)
Product code
IYB Tube Mount, X-Ray, Diagnostic
Regulation
21 CFR 892.1770
Device class
Class I
Review panel
Radiology
Applicant
Wuestec Medical, Inc. 1812 15th St., Mobile AL
510(k) summary
Statement
Third party review
No

Clearances, product code IYB

Trailing 12 months

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

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