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FDA 510(k)

OMNI LAPAROSCOPE

K-Number: K922319 · 1993-04-23

ApplicantExpanded Optics, Inc.
Decision Date1993-04-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNI LAPAROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Expanded Optics, Inc.. It received FDA 510(k) clearance on 1993-04-23 under 510(k) number K922319. 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 OMNI LAPAROSCOPE?

OMNI LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1993-04-23. The listed applicant is Expanded Optics, Inc.. The 510(k) number is K922319.

When did OMNI LAPAROSCOPE receive FDA 510(k) clearance?

OMNI LAPAROSCOPE received FDA 510(k) clearance on 1993-04-23, under 510(k) number K922319.

Who is the listed applicant for OMNI LAPAROSCOPE?

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

What is the FDA product code for OMNI LAPAROSCOPE?

The FDA product code for OMNI LAPAROSCOPE is GCJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Expanded Optics, 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.

K922321OMNI ARTHROSCOPEK922320OMNI CYSTOSCOPEK894570UNIVERSAL LIGHT CABLE

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

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

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