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HOPKINS Telescopes

by Karl Storz Endoscopy-America, Inc. 3 variants

510(k) K221004

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221004 Date20 Dec 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
FDA applicant
Karl Storz Endoscopy America, Inc.
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

HOPKINS Telescopes are optical instruments used in urologic and gastroenterologic procedures. They are designed to provide visualization during endoscopic surgical interventions.

These telescopes are supplied by Karl Storz Endoscopy-America, Inc. and are intended for use in clinical settings. They are delicate optical instruments that require careful handling to prevent damage or breakage during surgical procedures.

Other devices from Karl Storz Endoscopy-America, Inc.

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Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are HOPKINS Telescopes used for?

    HOPKINS Telescopes are optical instruments used in urologic and gastroenterologic procedures. They provide visualization during endoscopic surgical interventions, allowing clinicians to examine internal structures with precision.

  • Who supplies HOPKINS Telescopes?

    HOPKINS Telescopes are supplied by Karl Storz Endoscopy-America, Inc., based in El Segundo, California. The company specializes in endoscopic equipment and surgical visualization systems.

  • How should HOPKINS Telescopes be handled?

    HOPKINS Telescopes are delicate optical instruments that require careful handling to prevent damage or breakage during surgical procedures. Proper storage, cleaning, and inspection are essential to maintain optical clarity and functionality.

  • Are HOPKINS Telescopes reusable?

    The device data does not specify whether HOPKINS Telescopes are single-use or reusable. However, given their designation as delicate optical instruments for surgical procedures, they are typically designed for repeated use with proper sterilization and maintenance protocols.

  • What regulatory pathway was used for HOPKINS Telescopes?

    HOPKINS Telescopes were authorized through the FDA 510(k) premarket notification process. The submission (K221004) received a substantially equivalent decision on December 20, 2022, under product code GCJ, reviewed by the Gastroenterology and Urology advisory committee.