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Ksea Miniature Telescope and Accessories

by Karl Storz Endoscopy-America, Inc.

510(k) K010987

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 NumberK010987 Date19 Jun 2001ClearedStatusActive

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Ksea Miniature Telescope and Accessories is a device intended for use in orthopedic procedures. It is a miniature telescope system designed for visualization during surgical interventions.

This device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user. It is regulated under FDA 510(k) clearance K010987, with a traditional clearance pathway and product code HRX. The device was cleared on June 19, 2001, following a 78-day review.

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Questions

AI-generated answers, 26 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 is the KSEA Miniature Telescope and Accessories intended for?

    The KSEA Miniature Telescope and Accessories is intended for use in orthopedic procedures to provide visualization during surgical interventions, as specified in its device description.

  • Is the KSEA Miniature Telescope and Accessories supplied sterile or non-sterile, and is it single-use or reusable?

    The device is supplied non-sterile and is designed for reusable use after appropriate cleaning and sterilization by the user, meaning it is not intended for single-use applications.

  • What regulatory pathway and clearance information applies to the KSEA Miniature Telescope and Accessories?

    The KSEA Miniature Telescope and Accessories received FDA 510(k) clearance under number K010987 via a traditional clearance pathway, with a substantially equivalent decision based on its product code HRX and orthopedic advisory committee review.