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FDA 510(k)

MODIFICATION TO KSEA ENDOTIP SYSTEM

K-Number: K011359 · 2001-06-28

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2001-06-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO KSEA ENDOTIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2001-06-28 under 510(k) number K011359. 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 MODIFICATION TO KSEA ENDOTIP SYSTEM?

MODIFICATION TO KSEA ENDOTIP SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-28. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K011359.

When did MODIFICATION TO KSEA ENDOTIP SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO KSEA ENDOTIP SYSTEM received FDA 510(k) clearance on 2001-06-28, under 510(k) number K011359.

Who is the listed applicant for MODIFICATION TO KSEA ENDOTIP SYSTEM?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO KSEA ENDOTIP SYSTEM?

The FDA product code for MODIFICATION TO KSEA ENDOTIP SYSTEM is GCJ.

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Other records listing KARL STORZ Endoscopy-America, 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

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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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