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FDA 510(k)

KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING

K-Number: K973068 · 1997-11-07

ApplicantKarl Storz Endoskop GmbH
Decision Date1997-11-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoskop GmbH. It received FDA 510(k) clearance on 1997-11-07 under 510(k) number K973068. 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 KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING?

KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING is a medical device that received FDA 510(k) clearance on 1997-11-07. The listed applicant is Karl Storz Endoskop GmbH. The 510(k) number is K973068.

When did KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING receive FDA 510(k) clearance?

KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING received FDA 510(k) clearance on 1997-11-07, under 510(k) number K973068.

Who is the listed applicant for KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING?

The FDA 510(k) record lists Karl Storz Endoskop GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING?

The FDA product code for KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING is GCJ.

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Other records listing Karl Storz Endoskop GmbH 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.

K961702KSEA VAPORIZATION ELECTRODESK953368LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBESK943713TORCARS,CANNULAE,SHEATHS,OBTURATORSK951995KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTORK943053KSEA SEMM TISSUR PUNCHK943435CHOLANGIOGRAPHY SET

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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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