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Tablet Application

by Smith & Nephew, Inc.

510(k) K203566

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 NumberK203566 Date13 May 2021ClearedStatusActive

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  • Withdrawn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
FDA applicant
Smith & Nephew
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Tablet Application is an Endoscopic Central Control Unit, a software application that provides a Wi-Fi connection between compatible medical devices, allowing for limited remote control of the connected devices. It is used in the fields of Gastroenterology and Urology.

The Tablet Application is supplied as a medical-grade device and is intended to provide wireless control of compatible surgical and endoscopic devices within the operating room. It has received FDA 510(k) clearance and is classified as a Class 2 device with the regulation number 876.1500.

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Questions

AI-generated answers, 27 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 Tablet Application used for?

    The Tablet Application is used to provide wireless control of compatible surgical and endoscopic devices within the operating room, specifically in the fields of Gastroenterology and Urology.

  • Is the Tablet Application supplied as a sterile device?

    The description does not explicitly state that the Tablet Application is supplied sterile, but it is described as a medical-grade device.

  • What type of clearance has the Tablet Application received?

    The Tablet Application has received FDA 510(k) clearance, classified as a Class 2 device with the regulation number 876.1500, indicating it is substantially equivalent to a predicate device.

  • Can the Tablet Application be used with any medical device?

    No, the Tablet Application is designed to work with compatible medical devices, but the specific list of compatible devices is not provided in the available information.