Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console
FDA 510(k) K053436 · Cryocath Technologies, Inc.
510(k) numberK053436
Submission
- Device name
- Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console
- Applicant
- Cryocath Technologies, Inc.
Brookline, MA, US - Received
- December 9, 2005
- Decision date
- January 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCL – Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Other 510(k)s with product code OCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)OCL · Special | AtriCure, Inc. | 07/24/2025SE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH)OCL · Traditional | AtriCure, Inc. | 08/27/2024SE |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | AtriCure, Inc. | 12/30/2022SE |
| K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…OCL · Special | Medtronic, Inc. | 12/22/2022SE |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEOCL · Traditional | AtriCure, Inc. | 07/26/2021SE |
| K211311 | AtriCure Isolator® Synergy Surgical Ablation SystemOCL · Special | AtriCure, Inc. | 05/28/2021SE |
| K200514 | Cardioblate Gemini-s Surgical Ablation DeviceOCL · Traditional | Medtronic | 06/03/2020SE |
| K193162 | EPi-Sense Guided Coagulation System with VisiTraxOCL · Special | AtriCure, Inc. | 12/13/2019SE |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenOCL · Special | AtriCure, Inc. | 11/04/2019SE |
| K191526 | Cardioblate CryoFlex Surgical Ablation SystemOCL · Special | Medtronic, Inc. | 10/01/2019SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12DRA · Special | 06/27/2008SE |
| K070357 | Flexcath Steerable Sheath & DilatorDRA · Traditional | 12/28/2007SE |
| K062140 | Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1OCL · Special | 08/24/2006SE |
| K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleOCL · Special | 04/29/2004SE |
| K030303 | Freezor Xtra Surgical Cardiac Cryoablation Device and CCT.2 Cardiac Cardiac Cryoablation…GEH · Traditional | 04/29/2003SE |
Questions and answers
When was Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console cleared by the FDA?
Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console (K053436) received a 510(k) decision of Substantially Equivalent on January 13, 2006, 35 days after the submission was received.
What is the product code of K053436?
The FDA product code is OCL – Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, a Class II (moderate risk) device regulated under 21 CFR 878.4400.