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FDA 510(k)

LAPAROSCOPIC INTRODUCER

K-Number: K922082 · 1992-08-03

ApplicantEndomedix
Decision Date1992-08-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Endomedix. It received FDA 510(k) clearance on 1992-08-03 under 510(k) number K922082. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPIC INTRODUCER?

LAPAROSCOPIC INTRODUCER is a medical device that received FDA 510(k) clearance on 1992-08-03. The listed applicant is Endomedix. The 510(k) number is K922082.

When did LAPAROSCOPIC INTRODUCER receive FDA 510(k) clearance?

LAPAROSCOPIC INTRODUCER received FDA 510(k) clearance on 1992-08-03, under 510(k) number K922082.

Who is the listed applicant for LAPAROSCOPIC INTRODUCER?

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

What is the FDA product code for LAPAROSCOPIC INTRODUCER?

The FDA product code for LAPAROSCOPIC INTRODUCER is GCJ.

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Other records listing Endomedix 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.

K934170ENDOMEDIX Y-ADAPTERK934623ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERAK930499GRASPING FORCEPS FLEXIBLE STONE DISLODGERK930349STONE RETRIEVAL BASKETK926004ENDOSCOPE AND ACCOSSORIESK922837S1500 XENON LIGHT SOURCE

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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