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FDA 510(k)

KRYMED LIQUID NITROGEN CRYOJET

K-Number: K800335 · 1980-04-04

ApplicantCryomedics, Inc.
Decision Date1980-04-04
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KRYMED LIQUID NITROGEN CRYOJET is the device name listed in this FDA 510(k) record. The listed applicant is Cryomedics, Inc.. It received FDA 510(k) clearance on 1980-04-04 under 510(k) number K800335. 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 KRYMED LIQUID NITROGEN CRYOJET?

KRYMED LIQUID NITROGEN CRYOJET is a medical device that received FDA 510(k) clearance on 1980-04-04. The listed applicant is Cryomedics, Inc.. The 510(k) number is K800335.

When did KRYMED LIQUID NITROGEN CRYOJET receive FDA 510(k) clearance?

KRYMED LIQUID NITROGEN CRYOJET received FDA 510(k) clearance on 1980-04-04, under 510(k) number K800335.

Who is the listed applicant for KRYMED LIQUID NITROGEN CRYOJET?

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

What is the FDA product code for KRYMED LIQUID NITROGEN CRYOJET?

The FDA product code for KRYMED LIQUID NITROGEN CRYOJET is GEH.

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Other records listing Cryomedics, Inc. 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.

K851152MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULARK844431YN CO2 LASER SYSTEM 30WK842888DUAL CHANNEL TENS, PULSAR REMOTE CONTRLK842959MC-4000 CONSOLE & PROBESK842704MT-700 MT-750 FT-350K801730KRYMED SYSTEM 4001 TILT SCOPE

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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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