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FDA 510(k)

KSEA MEDI PACK

K-Number: K022490 · 2003-09-29

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2003-09-29
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KSEA MEDI PACK 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 2003-09-29 under 510(k) number K022490. The device is classified under product code GCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA MEDI PACK?

KSEA MEDI PACK is a medical device that received FDA 510(k) clearance on 2003-09-29. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K022490.

When did KSEA MEDI PACK receive FDA 510(k) clearance?

KSEA MEDI PACK received FDA 510(k) clearance on 2003-09-29, under 510(k) number K022490.

Who is the listed applicant for KSEA MEDI PACK?

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 KSEA MEDI PACK?

The FDA product code for KSEA MEDI PACK is GCT.

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

View all 355 devices →

Related Devices (Code: GCT)

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.

K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbHK082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed LinvatecK040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp.K023468ENDOSCOPIC LIGHT SOURCE XL180/L3World of Medicine Lemke GmbH

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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