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Dci Endoscope

by Karl Storz Endoscopy-America, Inc. 5 variants

510(k) K983363

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 NumberK983363 Date18 Dec 1998ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Dci Endoscope is a rigid panoramic telescope designed for endoscopic examination, employing rod lens technology to transmit high‑quality images. It is constructed with surgical‑grade stainless steel body contact portions.

The device was cleared through the FDA 510(k) pathway (decision date 1998-12-18) and is classified as a Class II device under product code GCJ. It is submitted by Karl Storz Endoscopy-America, Inc., located in Culver City, CA, United States. The clearance indicates substantial equivalence to a predicate device and the endoscope is supplied as a single unit for clinical use.

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Questions

AI-generated answers, 1 Oct 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 DCI Endoscope used for?

    The DCI Endoscope is a rigid panoramic telescope designed for endoscopic examination. It employs rod lens technology to transmit high-quality images and is constructed with surgical-grade stainless steel for body contact portions.

  • How is the DCI Endoscope supplied?

    The DCI Endoscope is supplied as a single unit for clinical use. It is designed for endoscopic examination procedures and comes ready for use in medical settings.

  • What is the regulatory status of the DCI Endoscope?

    The DCI Endoscope was cleared through the FDA 510(k) pathway on December 18, 1998. It is classified as a Class II device under product code GCJ and is considered substantially equivalent to a predicate device.

  • Is the DCI Endoscope reusable or single-use?

    The DCI Endoscope is designed for clinical use, but the device data does not specify whether it is intended for single-use or multiple reuses. The stainless steel construction suggests it may be designed for multiple uses, but this should be confirmed with the manufacturer.