510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911901Substantially Equivalent

Maxi Cabinet Optional Built in S6000 Light Source

Stortz, Saint Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911901 is the FDA 510(k) clearance record for MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE, a class I device, cleared for Stortz on under FDA product code ETF (Unit, Examining/Treatment, Ent). FDA records list one 510(k) clearance for Stortz. As of , FDA records show no recalls naming K911901.

Clearance record

Decision date
Received
(88 days to decision)
Product code
ETF Unit, Examining/Treatment, Ent
Regulation
21 CFR 874.5300
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Stortz 3365 Tree Ct. Ind. Blvd., Saint Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code ETF

Trailing 12 months

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

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