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FDA 510(k)

SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER

K-Number: K972109 · 1997-11-14

ApplicantGeneral Surgical Innovations
Decision Date1997-11-14
Product CodeFZW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER 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 1997-11-14 under 510(k) number K972109. The device is classified under product code FZW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER?

SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER is a medical device that received FDA 510(k) clearance on 1997-11-14. The listed applicant is General Surgical Innovations. The 510(k) number is K972109.

When did SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER receive FDA 510(k) clearance?

SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER received FDA 510(k) clearance on 1997-11-14, under 510(k) number K972109.

Who is the listed applicant for SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER?

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 SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER?

The FDA product code for SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER is FZW.

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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, SAPHTRAKK970201GSI CANNULA WITH INTRODUCERK962702SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULAK961356MAMMARY SIZERK952278THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA

View all 14 devices →

Related Devices (Code: FZW)

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.

K080158LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEMLb Medical LLCK984448BIRCOLL BALLOON DISSECTORWells Johnson Co.K936186AESCULAP SKIN GRAFT MESHERAesculap, Inc.K904265INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERInamed Development Co.K902349SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDERSurgitekK883303MENTOR RAPID-SPAN (TM) TISSUE EXPANDERMentor Corp.

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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