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FDA 510(k)

AED LAPAROSCOPE

K-Number: K993688 · 1999-12-06

ApplicantNational Advanced Endoscopy Devices, Inc.
Decision Date1999-12-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AED LAPAROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is National Advanced Endoscopy Devices, Inc.. It received FDA 510(k) clearance on 1999-12-06 under 510(k) number K993688. 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 AED LAPAROSCOPE?

AED LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1999-12-06. The listed applicant is National Advanced Endoscopy Devices, Inc.. The 510(k) number is K993688.

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

AED LAPAROSCOPE received FDA 510(k) clearance on 1999-12-06, under 510(k) number K993688.

Who is the listed applicant for AED LAPAROSCOPE?

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

What is the FDA product code for AED LAPAROSCOPE?

The FDA product code for AED LAPAROSCOPE is GCJ.

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Other records listing National Advanced Endoscopy Devices, 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.

K170285AED SinuscopeK102663AED RESECTOSCOPEK081553AED BIPOLAR FORCEPS, MODEL 13-1646K081503AED MONOPOLAR LAP ACCESSORIESK993689AED CYSTOSCOPEK991656AED ARTHROSCOPE

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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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