510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923818Substantially Equivalent

O.r. Concepts' Irrigating Kittner

O.R. Concepts, Inc., Roanoke TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923818 is the FDA 510(k) clearance record for O.R. CONCEPTS' IRRIGATING KITTNER, a class II device, cleared for O.R. Concepts, Inc. on under FDA product code FGS (Carrier, Sponge, Endoscopic). FDA records list 34 510(k) clearances for O.R. Concepts, Inc., from to . As of , FDA records show no recalls naming K923818.

Clearance record

Decision date
Received
(251 days to decision)
Product code
FGS Carrier, Sponge, Endoscopic
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
O.R. Concepts, Inc. 200 N. Oak St., Roanoke TX
510(k) summary
Statement
Third party review
No

Clearances, product code FGS

Trailing 12 months

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

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