Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)

K-Number: K954021 · 1995-10-24

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1995-10-24
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1995-10-24 under 510(k) number K954021. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)?

EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) is a medical device that received FDA 510(k) clearance on 1995-10-24. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K954021.

When did EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) receive FDA 510(k) clearance?

EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) received FDA 510(k) clearance on 1995-10-24, under 510(k) number K954021.

Who is the listed applicant for EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)?

The FDA product code for EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) is JXG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Johnson & Johnson Professionals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992173SIPHONGUARD CSF CONTROL DEVICEK991413CODMAN ETHISORB DURA PATCHK991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITK982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERK982812G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

View all 206 devices →

Related Devices (Code: JXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260044Ventricular Catheters, Thomale CatheterAesculap, Inc.K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑