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
K173763Substantially Equivalent

iovera system

Myoscience, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173763 is the FDA 510(k) clearance record for iovera system, a class II device, cleared for Myoscience, Inc. on under FDA product code GXH (Device, Surgical, Cryogenic). FDA records list 9 510(k) clearances for Myoscience, Inc., from to . As of , FDA records show no recalls naming K173763.

Clearance record

Decision date
Received
(79 days to decision)
Product code
GXH Device, Surgical, Cryogenic
Regulation
21 CFR 882.4250
Device class
Class II
Review panel
Neurology
Applicant
Myoscience, Inc. 46400 Fremont Blvd., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXH

Trailing 12 months

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

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