510(k) Report

FDA applicant

Cryocath Technologies, Inc.

Kirkland, CA6 decisions2003–20081 recall

FDA records 6 decisions for Cryocath Technologies, Inc. (Kirkland, CA) from 2003 to 2008: 6 510(k) clearances. Most are in product codes OCL (Surgical Device, For Cutting, Coagulation…) and DRA (Catheter, Steerable). Its devices cite 19 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cryocath Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac…3decisions
  • DRACatheter, Steerable2decisions
  • GEHUnit, Cryosurgical, Accessories1decision

Whose devices does it build on?

Its devices cite 19 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 4 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.

  • K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 20044cite it
  • K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 20064cite it
  • K081049Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 20082cite it
  • K070357Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 20071cites it
  • K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc. · 20061cites it

What has FDA decided for it lately?

  • K081049Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 2008
  • K070357Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 2007
  • K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc. · 2006
  • K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 20061 recall
  • K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004
  • K030303Freezor Xtra Surgical Cardiac Cryoablation Device and CCT.2 Cardiac Cardiac Cryoablation CryoconsoleCryocath Technologies, Inc. · 2003

All 6 as Cryocath Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K053436CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies…May 5, 2006