510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111985Substantially Equivalent

Myoguide System Model 8008

Intronix Technologies Corp., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111985 is the FDA 510(k) clearance record for MYOGUIDE SYSTEM MODEL 8008, a class II device, cleared for Intronix Technologies Corp. on under FDA product code BXN (Stimulator, Nerve, Battery-Powered). FDA records list one 510(k) clearance for Intronix Technologies Corp. As of , FDA records show no recalls naming K111985.

Clearance record

Decision date
Received
(171 days to decision)
Product code
BXN Stimulator, Nerve, Battery-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Intronix Technologies Corp. 611 W. 5th St., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BXN

Trailing 12 months

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

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