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DCI Endoscope

by Karl Storz Endoscopy-America, Inc. 510(k)

Active United States

510(k) K990004

Overview

The DCI Endoscope is a rigid, panoramic laparoscope designed for gynecologic and obstetric procedures. It employs rod lens technology to provide high-quality imaging through a rigid stainless steel body, ensuring durability and biocompatibility for surgical applications.

This device is intended for use in operating rooms and clinical settings requiring laparoscopic visualization. Supplied as a reusable instrument, it adheres to FDA 510(k) clearance under the traditional review pathway. The body contact portions are constructed from surgical-grade stainless steel, meeting regulatory standards for medical device biocompatibility. No MRI safety or sterility specifications are explicitly stated in the provided data.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990004 Date2 Apr 1999ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of surgical procedures is the DCI Endoscope primarily designed for, and why is rod lens technology used in its construction?

    The DCI Endoscope is specifically designed for gynecologic and obstetric procedures, providing high-quality laparoscopic visualization in operating rooms. Rod lens technology is employed to enhance image clarity and resolution through the rigid stainless steel body, ensuring durable and precise surgical imaging.

  • Is the DCI Endoscope intended for single-use or reusable applications, and what material is used for the body contact portions?

    The DCI Endoscope is supplied as a reusable instrument. The body contact portions are constructed from surgical-grade stainless steel, which meets regulatory standards for biocompatibility and durability in medical applications.

  • How was the DCI Endoscope’s regulatory pathway determined, and what does the advisory committee classification indicate about its intended use?

    The DCI Endoscope was cleared under the FDA’s 510(k) traditional review pathway, classified as substantially equivalent to existing devices. The advisory committee classification under Obstetrics/Gynecology reflects its intended application in surgical settings for laparoscopic visualization in those specialties, though it does not define clinical indications.

  • Are there any specific storage or handling requirements mentioned for the DCI Endoscope?

    The provided data does not explicitly detail storage or handling instructions for the DCI Endoscope. However, as a reusable stainless steel device, proper cleaning, sterilization, and maintenance protocols should follow standard medical device guidelines to ensure durability and safety.