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FDA 510(k)

POINT SETTER

K-Number: K984355 · 1999-04-01

ApplicantMitaka USA, Inc.
Decision Date1999-04-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

POINT SETTER is the device name listed in this FDA 510(k) record. The listed applicant is Mitaka USA, Inc.. It received FDA 510(k) clearance on 1999-04-01 under 510(k) number K984355. 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 POINT SETTER?

POINT SETTER is a medical device that received FDA 510(k) clearance on 1999-04-01. The listed applicant is Mitaka USA, Inc.. The 510(k) number is K984355.

When did POINT SETTER receive FDA 510(k) clearance?

POINT SETTER received FDA 510(k) clearance on 1999-04-01, under 510(k) number K984355.

Who is the listed applicant for POINT SETTER?

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

What is the FDA product code for POINT SETTER?

The FDA product code for POINT SETTER 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.

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Other records listing Mitaka USA, 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.

K991989MITAKA POINT SETTER

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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