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FDA 510(k)

LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS

K-Number: K924134 · 1993-07-02

ApplicantLeisegang Medical, Inc.
Decision Date1993-07-02
Product CodeGCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS 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 1993-07-02 under 510(k) number K924134. The device is classified under product code GCS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS?

LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS is a medical device that received FDA 510(k) clearance on 1993-07-02. The listed applicant is Leisegang Medical, Inc.. The 510(k) number is K924134.

When did LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS receive FDA 510(k) clearance?

LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS received FDA 510(k) clearance on 1993-07-02, under 510(k) number K924134.

Who is the listed applicant for LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS?

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 LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS?

The FDA product code for LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS is GCS.

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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 ACCESSORIESK920217MAX-E-VACK914201LM- LAP 10 HIGH FLOW INSUFFLATORK912789LM-100/200LOW FLOW INSUFFLATORK913135LM-300TWIN

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Related Devices (Code: GCS)

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.

K944062LAPRASCOPIC GRASPERInstrument Makar, Inc.K944067PEANUT WAND, MODIFICATIONIdeal Medical, Inc.K933201AESCULAP TROCAR INSTRUMENT SETAesculap, Inc.K93276210.0MM SUCTION/IRRIGATION PROBE & TUBING KITInman Medical Corp.K933371IMC ENDOSCOPIC INSTRUMENT HOLDERInman Medical Corp.K931340GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTORBaxter Healthcare Corp

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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