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FDA 510(k)

CURVILINEAR SUTURE PLACEMENT SYSTEM

K-Number: K973415 · 1997-12-02

ApplicantLaurus Medical Corp.
Decision Date1997-12-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CURVILINEAR SUTURE PLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laurus Medical Corp.. It received FDA 510(k) clearance on 1997-12-02 under 510(k) number K973415. 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 CURVILINEAR SUTURE PLACEMENT SYSTEM?

CURVILINEAR SUTURE PLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-02. The listed applicant is Laurus Medical Corp.. The 510(k) number is K973415.

When did CURVILINEAR SUTURE PLACEMENT SYSTEM receive FDA 510(k) clearance?

CURVILINEAR SUTURE PLACEMENT SYSTEM received FDA 510(k) clearance on 1997-12-02, under 510(k) number K973415.

Who is the listed applicant for CURVILINEAR SUTURE PLACEMENT SYSTEM?

The FDA 510(k) record lists Laurus Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CURVILINEAR SUTURE PLACEMENT SYSTEM?

The FDA product code for CURVILINEAR SUTURE PLACEMENT SYSTEM is GCJ.

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 Laurus Medical Corp. 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.

K973215STEREOTACTIC NEEDLE CORE BIOPSY SYSTEMK960317LAURUS NEEDLE CORE BIOPSY SYSTEMK932553DISPOSABLE SUTURE PLACEMENT SYSTEM

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

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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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