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FDA 510(k)

SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101

K-Number: K991382 · 1999-07-15

ApplicantGenicon, LC
Decision Date1999-07-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 is the device name listed in this FDA 510(k) record. The listed applicant is Genicon, LC. It received FDA 510(k) clearance on 1999-07-15 under 510(k) number K991382. 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 SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101?

SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 is a medical device that received FDA 510(k) clearance on 1999-07-15. The listed applicant is Genicon, LC. The 510(k) number is K991382.

When did SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 receive FDA 510(k) clearance?

SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 received FDA 510(k) clearance on 1999-07-15, under 510(k) number K991382.

Who is the listed applicant for SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101?

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

What is the FDA product code for SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101?

The FDA product code for SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 is GCJ.

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Other records listing Genicon, LC 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.

K030174GENICON LAPAROSCOPESK030269GENICON CLIP APPLIERK002542REUSABLE CANNULAK993625INSUFFLATION NEEDLE- 120MM, MODEL 900-200K982472GENICON TROCAR

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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