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FDA 510(k)

THE SPACEMAKER AND THE SPACEMAKER II

K-Number: K944418 · 1994-11-01

ApplicantGeneral Surgical Innovations
Decision Date1994-11-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE SPACEMAKER AND THE SPACEMAKER II is the device name listed in this FDA 510(k) record. The listed applicant is General Surgical Innovations. It received FDA 510(k) clearance on 1994-11-01 under 510(k) number K944418. 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 THE SPACEMAKER AND THE SPACEMAKER II?

THE SPACEMAKER AND THE SPACEMAKER II is a medical device that received FDA 510(k) clearance on 1994-11-01. The listed applicant is General Surgical Innovations. The 510(k) number is K944418.

When did THE SPACEMAKER AND THE SPACEMAKER II receive FDA 510(k) clearance?

THE SPACEMAKER AND THE SPACEMAKER II received FDA 510(k) clearance on 1994-11-01, under 510(k) number K944418.

Who is the listed applicant for THE SPACEMAKER AND THE SPACEMAKER II?

The FDA 510(k) record lists General Surgical Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE SPACEMAKER AND THE SPACEMAKER II?

The FDA product code for THE SPACEMAKER AND THE SPACEMAKER II is GCJ.

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Other records listing General Surgical Innovations 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.

K983318FIXATION SYSTEMK973046SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAKK972109SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERK970201GSI CANNULA WITH INTRODUCERK962702SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULAK961356MAMMARY SIZER

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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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