510(k) Report

FDA applicant

Myoscience, Inc.

Redwood City, CA9 decisions2009–20182 recalls

FDA records 9 decisions for Myoscience, Inc. (Redwood City, CA) from 2009 to 2018: 9 510(k) clearances. Most are in product codes GXH (Device, Surgical, Cryogenic) and GEH (Unit, Cryosurgical, Accessories). Its devices cite 16 predicates, 10 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Myoscience, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2009: 12010: 22012: 12013: 12014: 12015: 12017: 12018: 1
2009high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2015

2013: 12015: 1
2009high 1 (2013) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Myoscience, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Myoscience, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GXHDevice, Surgical, Cryogenic8decisions
  • GEHUnit, Cryosurgical, Accessories1decision

Whose devices does it build on?

Its devices cite 16 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161835iovera systemMyoscience, Inc. · 20172cite it
  • K102021Cryo-Touch IIMyoscience, Inc. · 20102cite it
  • K083493Myoscience Cryo-TouchMyoscience, Inc. · 20092cite it
  • K142866Myoscience iovera systemMyoscience, Inc. · 20151cites it
  • K120415Cryo-Touch IiiMyoscience, Inc. · 20121cites it
  • K133453IoveraMyoscience, Inc. · 20141cites it

What has FDA decided for it lately?

  • K173763iovera systemMyoscience, Inc. · 2018
  • K161835iovera systemMyoscience, Inc. · 2017
  • K142866Myoscience iovera systemMyoscience, Inc. · 20151 recall
  • K133453IoveraMyoscience, Inc. · 2014
  • K123516Cryo-Touch IVMyoscience, Inc. · 20131 recall
  • K120415Cryo-Touch IiiMyoscience, Inc. · 2012
  • K102021Cryo-Touch IIMyoscience, Inc. · 2010
  • K100447Myoscience Cryo-TouchMyoscience, Inc. · 2010

All 9 as Myoscience, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K142866iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count…Jul 1, 2015Class II
  • K123516Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical…Jun 21, 2013Class II