510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K972055Substantially Equivalent

Msi Magna-Stym

Microvas Systems, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972055 is the FDA 510(k) clearance record for MSI MAGNA-STYM, a class II device, cleared for Microvas Systems, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list one 510(k) clearance for Microvas Systems, Inc. As of , FDA records show no recalls naming K972055.

Clearance record

Decision date
Received
(88 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Microvas Systems, Inc. 400 N. Loop 1604, Suite 340, San Antonio TX
510(k) summary
Statement
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260