FDA 510(k)

SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1

K-Number: K062140 · 2006-08-24

Decision Date2006-08-24

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 is the device name listed in this FDA 510(k) record. The listed applicant is Cryocath Technologies, Inc.. It received FDA 510(k) clearance on 2006-08-24 under 510(k) number K062140. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1?

SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 is a medical device that received FDA 510(k) clearance on 2006-08-24. The listed applicant is Cryocath Technologies, Inc.. The 510(k) number is K062140.

When did SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 receive FDA 510(k) clearance?

SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 received FDA 510(k) clearance on 2006-08-24, under 510(k) number K062140.

Who is the listed applicant for SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1?

The FDA 510(k) record lists Cryocath Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1?

The FDA product code for SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 is OCL.

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Other records listing Cryocath Technologies, Inc. as applicant

K081049FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 K070357FLEXCATH STEERABLE SHEATH & DILATOR K053436SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE K040690SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE K030303FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.