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FDA 510(k)

HOPKINS Telescopes for Arthroscopy

K-Number: K254103 · 2026-08-26

ApplicantKarl Storz SE & CO. KG
Decision Date2026-08-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOPKINS Telescopes for Arthroscopy is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-08-26 under 510(k) number K254103. 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 HOPKINS Telescopes for Arthroscopy?

HOPKINS Telescopes for Arthroscopy is a medical device that received FDA 510(k) clearance on 2026-08-26. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K254103.

When did HOPKINS Telescopes for Arthroscopy receive FDA 510(k) clearance?

HOPKINS Telescopes for Arthroscopy received FDA 510(k) clearance on 2026-08-26, under 510(k) number K254103.

Who is the listed applicant for HOPKINS Telescopes for Arthroscopy?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOPKINS Telescopes for Arthroscopy?

The FDA product code for HOPKINS Telescopes for Arthroscopy is HRX.

Other records listing Karl Storz SE & CO. KG as applicant

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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.K252790Digital 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)K250795PUREVUE™ FMSW.O.M. World of Medicine 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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