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FDA 510(k)

GSI CANNULA WITH INTRODUCER

K-Number: K970201 · 1997-04-21

ApplicantGeneral Surgical Innovations
Decision Date1997-04-21
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GSI CANNULA WITH INTRODUCER 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 1997-04-21 under 510(k) number K970201. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSI CANNULA WITH INTRODUCER?

GSI CANNULA WITH INTRODUCER is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is General Surgical Innovations. The 510(k) number is K970201.

When did GSI CANNULA WITH INTRODUCER receive FDA 510(k) clearance?

GSI CANNULA WITH INTRODUCER received FDA 510(k) clearance on 1997-04-21, under 510(k) number K970201.

Who is the listed applicant for GSI CANNULA WITH INTRODUCER?

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 GSI CANNULA WITH INTRODUCER?

The FDA product code for GSI CANNULA WITH INTRODUCER is DYB.

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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/EXPANDERK962702SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULAK961356MAMMARY SIZERK952278THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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