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Solos Cideo Camera Replacement Cable 800/900 Series

by Woodbine Optical Corp.

510(k) K970056

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 NumberK970056 Date28 Jan 1997ClearedStatusActive

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  • Withdrawn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, 26 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 Solos Cideo Camera Replacement Cable 800/900 Series is a laparoscope accessory used in general and plastic surgery. It functions as a replacement cable for camera systems to maintain connectivity during surgical procedures.

This device is classified as a Class II medical device under product code GCJ. It has received FDA 510(k) clearance under K970056, confirming it is substantially equivalent to existing devices.

Other devices from Woodbine Optical Corp.

Questions

AI-generated answers, 26 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 primary function of the Solos Cideo Camera Replacement Cable?

    This device serves as a replacement cable for camera systems used in general and plastic surgery. Its purpose is to ensure consistent connectivity for laparoscope equipment throughout surgical procedures.

  • Which surgical systems is this replacement cable compatible with?

    The cable is specifically designed for use with the Solos Cideo 800 and 900 series camera systems to ensure proper integration and performance during medical operations.

  • What is the regulatory status of this device?

    The Solos Cideo Camera Replacement Cable has received FDA 510(k) clearance under K970056. This clearance confirms that the device is substantially equivalent to existing devices already on the market.