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FDA 510(k)

CORE AUDIBLE TROCAR II

K-Number: K992250 · 1999-09-24

ApplicantCore Dynamics, Inc.
Decision Date1999-09-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORE AUDIBLE TROCAR II is the device name listed in this FDA 510(k) record. The listed applicant is Core Dynamics, Inc.. It received FDA 510(k) clearance on 1999-09-24 under 510(k) number K992250. 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 CORE AUDIBLE TROCAR II?

CORE AUDIBLE TROCAR II is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Core Dynamics, Inc.. The 510(k) number is K992250.

When did CORE AUDIBLE TROCAR II receive FDA 510(k) clearance?

CORE AUDIBLE TROCAR II received FDA 510(k) clearance on 1999-09-24, under 510(k) number K992250.

Who is the listed applicant for CORE AUDIBLE TROCAR II?

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

What is the FDA product code for CORE AUDIBLE TROCAR II?

The FDA product code for CORE AUDIBLE TROCAR II is GCJ.

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Other records listing Core Dynamics, 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.

K992190CORE POUCHK955490LAPAROSCOPIC KNITTERK953903LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MMK953409LAPAROSCOPIC TROCARK950457CANNUAL AND TROCAR, SUPERPUBICK943172CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR

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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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