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FDA 510(k)

LM 1000

K-Number: K854767 · 1986-01-24

ApplicantLeisegang Medical, Inc.
Decision Date1986-01-24
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LM 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Leisegang Medical, Inc.. It received FDA 510(k) clearance on 1986-01-24 under 510(k) number K854767. 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 LM 1000?

LM 1000 is a medical device that received FDA 510(k) clearance on 1986-01-24. The listed applicant is Leisegang Medical, Inc.. The 510(k) number is K854767.

When did LM 1000 receive FDA 510(k) clearance?

LM 1000 received FDA 510(k) clearance on 1986-01-24, under 510(k) number K854767.

Who is the listed applicant for LM 1000?

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

What is the FDA product code for LM 1000?

The FDA product code for LM 1000 is GEH.

Other records listing Leisegang Medical, 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.

K990043SMOOTHLASE ALEXANDRITE LASER SYSTEMK940094COLPOSCOPES AND ACCESSORIESK924134LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESSK920217MAX-E-VACK914201LM- LAP 10 HIGH FLOW INSUFFLATORK912789LM-100/200LOW FLOW INSUFFLATOR

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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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