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FDA 510(k)

KSEA MINIATURE TELESCOPE AND ACCESSORIES

K-Number: K010987 · 2001-06-19

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2001-06-19
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KSEA MINIATURE TELESCOPE AND ACCESSORIES 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 2001-06-19 under 510(k) number K010987. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA MINIATURE TELESCOPE AND ACCESSORIES?

KSEA MINIATURE TELESCOPE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2001-06-19. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K010987.

When did KSEA MINIATURE TELESCOPE AND ACCESSORIES receive FDA 510(k) clearance?

KSEA MINIATURE TELESCOPE AND ACCESSORIES received FDA 510(k) clearance on 2001-06-19, under 510(k) number K010987.

Who is the listed applicant for KSEA MINIATURE TELESCOPE AND ACCESSORIES?

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 MINIATURE TELESCOPE AND ACCESSORIES?

The FDA product code for KSEA MINIATURE TELESCOPE AND ACCESSORIES is HRX.

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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: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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