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FDA 510(k)

SUTURE PLACEMENT DEVICE AND ACCESSORIES

K-Number: K981531 · 1998-07-13

ApplicantLsi Solutions
Decision Date1998-07-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUTURE PLACEMENT DEVICE AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Lsi Solutions. It received FDA 510(k) clearance on 1998-07-13 under 510(k) number K981531. 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 SUTURE PLACEMENT DEVICE AND ACCESSORIES?

SUTURE PLACEMENT DEVICE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1998-07-13. The listed applicant is Lsi Solutions. The 510(k) number is K981531.

When did SUTURE PLACEMENT DEVICE AND ACCESSORIES receive FDA 510(k) clearance?

SUTURE PLACEMENT DEVICE AND ACCESSORIES received FDA 510(k) clearance on 1998-07-13, under 510(k) number K981531.

Who is the listed applicant for SUTURE PLACEMENT DEVICE AND ACCESSORIES?

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

What is the FDA product code for SUTURE PLACEMENT DEVICE AND ACCESSORIES?

The FDA product code for SUTURE PLACEMENT DEVICE AND ACCESSORIES is GCJ.

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Other records listing Lsi Solutions 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.

K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureK163639LS-5 ePTFE SutureK040232LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999K031443LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTSK024301LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCTK011016LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT

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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.

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

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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