510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K931606Substantially Equivalent

7-510-25 Hysteromed Tubing Kit

Nortech, Arlington Heights IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931606 is the FDA 510(k) clearance record for 7-510-25 HYSTEROMED TUBING KIT, a class II device, cleared for Nortech on under FDA product code HIG (Insufflator, Hysteroscopic). FDA records list one 510(k) clearance for Nortech. As of , FDA records show no recalls naming K931606.

Clearance record

Decision date
Received
(298 days to decision)
Product code
HIG Insufflator, Hysteroscopic
Regulation
21 CFR 884.1700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Nortech 3930 Ventura Dr., Arlington Heights IL
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