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FDA 510(k)

KSEA UNIMAT 12

K-Number: K002700 · 2000-10-18

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2000-10-18
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KSEA UNIMAT 12 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 2000-10-18 under 510(k) number K002700. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA UNIMAT 12?

KSEA UNIMAT 12 is a medical device that received FDA 510(k) clearance on 2000-10-18. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K002700.

When did KSEA UNIMAT 12 receive FDA 510(k) clearance?

KSEA UNIMAT 12 received FDA 510(k) clearance on 2000-10-18, under 510(k) number K002700.

Who is the listed applicant for KSEA UNIMAT 12?

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 UNIMAT 12?

The FDA product code for KSEA UNIMAT 12 is EOB.

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 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: EOB)

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.

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KGK261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLC

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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