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Siemens Integrated Operating System (SIOS)

by Siemens Medical Corp.

510(k) K994231

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 NumberK994231 Date10 Aug 2000ClearedStatusActive

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  • Withdrawn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.

An endoscopic central control unit used in gastroenterology and urology procedures. It is designed to optimize operating room procedures by providing consistent preoperative, intraoperative, and postoperative equipment coordination.

Supplied as a reusable system for use in clinical settings. Authorized via FDA 510(k) clearance (K994231) and classified as a Class II device under regulation number 876.1500. No sterility, single-use, MRI safety, size, or storage specifications are provided in the data.

Other devices from Siemens Medical Corp.

Questions

AI-generated answers, 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.

  • What is the SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) used for?

    The SIOS is an endoscopic central control unit designed to optimize operating room procedures by providing consistent coordination of equipment during preoperative, intraoperative, and postoperative phases in gastroenterology and urology procedures.

  • How is the SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) supplied and is it reusable?

    The SIOS is supplied as a reusable system intended for use in clinical settings, meaning it is designed for multiple uses after appropriate cleaning and reprocessing between procedures.

  • What regulatory pathway was used for the SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)?

    The SIOS was authorized via FDA 510(k) clearance under submission K994231, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II device under regulation number 876.1500.