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FDA 510(k)

PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE

K-Number: K073671 · 2008-03-26

ApplicantNdo Surgical, Inc.
Decision Date2008-03-26
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Ndo Surgical, Inc.. It received FDA 510(k) clearance on 2008-03-26 under 510(k) number K073671. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE?

PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE is a medical device that received FDA 510(k) clearance on 2008-03-26. The listed applicant is Ndo Surgical, Inc.. The 510(k) number is K073671.

When did PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE receive FDA 510(k) clearance?

PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE received FDA 510(k) clearance on 2008-03-26, under 510(k) number K073671.

Who is the listed applicant for PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE?

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

What is the FDA product code for PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE?

The FDA product code for PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE is OCW.

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 Ndo Surgical, 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.

K072125ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENTK071553ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATORK032820MODIFICATION TO ENDOSCOPIC PLICATION SYSTEMK031262ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760K023234ENDOSCOPIC PLICATION SYSTEM

Related Devices (Code: OCW)

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.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

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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