Cordis Gravity Compensating Accessory

FDA 510(k) K932429 · Cordis Corp.

Substantially Equivalent

510(k) numberK932429

Submission

Device name
Cordis Gravity Compensating Accessory
Applicant
Cordis Corp.
Miami Lakes, FL, US
Received
May 20, 1993
Decision date
July 20, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code JXG

510(k)DeviceApplicantDecision
K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional Integra Lifesciences Production Corporation06/23/2026SE
K251598IntellidropJXG · Traditional Brainspace, Inc.12/10/2025SE
K250636Sophy Mini Monopressure Valve (SM1)JXG · Traditional Sophysa11/28/2025SE
K252514Evac-MriJXG · Traditional Phasor Health, LLC11/05/2025SESD
K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional Integra Lifesciences Production Corporation08/08/2025SE
K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional Integra Lifesciences Production Corporation08/06/2025SE
K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional Sophysa06/20/2025SE
K243205EvacJXG · Traditional Phasor Health, LLC06/03/2025SE
K243676Duet External Drainage and Monitoring System (EDMS)JXG · Traditional Medtronic Neurosurgery03/10/2025SE
K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional Aesculap, Inc.12/16/2024SE

More from Aesculap, Inc.

510(k)DeviceDecision
K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireNTE · Special 04/06/2022SE
K212977SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsDQO · Traditional 02/17/2022SE
K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterLIT · Traditional 04/23/2021SE
K202167Brite Tip Radianz Guiding SheathDYB · Traditional 02/26/2021SE
K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional 10/09/2020SE
K201333SABER .035 PTA Dilatation CatheterLIT · Traditional 09/11/2020SE
K181592RAIN Sheath TransradialDYB · Traditional 08/15/2018SE
K180081RAILWAY Sheathless Access SystemDYB · Traditional 04/18/2018SE
K143412ADROIT Guiding CatheterDQY · Special 01/14/2015SE
K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional 06/27/2014SE

Questions and answers

When was Cordis Gravity Compensating Accessory cleared by the FDA?

Cordis Gravity Compensating Accessory (K932429) received a 510(k) decision of Substantially Equivalent on July 20, 1994, 426 days after the submission was received.

What is the product code of K932429?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.