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Karl Storz SCB Interface Control, Model 20090120

by Karl Storz Endoscopy-America, Inc.

510(k) K070827

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 NumberK070827 Date22 May 2007ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 22 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 Karl Storz SCB Interface Control, Model 20090120 is an Endoscopic Central Control Unit designed for use with Karl Storz SCB integrated operating room and endoscopy systems. It provides centralized communication and control between compatible imaging and endoscopic equipment as part of an integrated system.

This device is supplied as a reusable control unit intended for use in clinical endoscopy and operating room settings. It is classified as a Class II medical device under FDA regulation number 876.1500 and has received FDA 510(k) clearance (K070827) as substantially equivalent to a predicate device. The device is not sterile, not single-use, and has no stated MRI safety restrictions in the provided data.

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