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FDA 510(k)

SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA

K-Number: K952444 · 1995-08-07

ApplicantAdjacent Surgical, Inc.
Decision Date1995-08-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Adjacent Surgical, Inc.. It received FDA 510(k) clearance on 1995-08-07 under 510(k) number K952444. 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 SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA?

SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Adjacent Surgical, Inc.. The 510(k) number is K952444.

When did SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA receive FDA 510(k) clearance?

SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA received FDA 510(k) clearance on 1995-08-07, under 510(k) number K952444.

Who is the listed applicant for SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA?

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

What is the FDA product code for SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA?

The FDA product code for SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA is GCJ.

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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.

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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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