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FDA 510(k)

CANDELA HCS 2000 URETHERAL WARMER CATHETER

K-Number: K955011 · 1996-04-03

ApplicantCandela Laser Corp.
Decision Date1996-04-03
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA HCS 2000 URETHERAL WARMER CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Candela Laser Corp.. It received FDA 510(k) clearance on 1996-04-03 under 510(k) number K955011. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDELA HCS 2000 URETHERAL WARMER CATHETER?

CANDELA HCS 2000 URETHERAL WARMER CATHETER is a medical device that received FDA 510(k) clearance on 1996-04-03. The listed applicant is Candela Laser Corp.. The 510(k) number is K955011.

When did CANDELA HCS 2000 URETHERAL WARMER CATHETER receive FDA 510(k) clearance?

CANDELA HCS 2000 URETHERAL WARMER CATHETER received FDA 510(k) clearance on 1996-04-03, under 510(k) number K955011.

Who is the listed applicant for CANDELA HCS 2000 URETHERAL WARMER CATHETER?

The FDA 510(k) record lists Candela Laser Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANDELA HCS 2000 URETHERAL WARMER CATHETER?

The FDA product code for CANDELA HCS 2000 URETHERAL WARMER CATHETER is GEH.

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Other records listing Candela Laser Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K951033ANDELA DYNAMIC COOLING DEVICEK955662CANDELA Q-SWITCHED ALEXANDRITE LASERSK954872CANDELA CRYO-PROBE HOLDERK954934CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASEK953412CANDELA MODEL PLTL-1 LASER SYSTEMK953294CANDELA CRYOSYSTEM CS-5

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Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

Official Source

View on FDA Database →

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

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