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
K922197Substantially Equivalent

Insufflator Tubing Kit

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

K922197 is the FDA 510(k) clearance record for INSUFFLATOR TUBING KIT, a class II device, cleared for O.R. Concepts, Inc. on under FDA product code HIG (Insufflator, Hysteroscopic). FDA records list 34 510(k) clearances for O.R. Concepts, Inc., from to . As of , FDA records show no recalls naming K922197.

Clearance record

Decision date
Received
(501 days to decision)
Product code
HIG Insufflator, Hysteroscopic
Regulation
21 CFR 884.1700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
O.R. Concepts, Inc. 200 N. Oak St., Roanoke TX
510(k) summary
Statement
Third party review
No

Clearances, product code HIG

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