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

FDA 510(k)

proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System

K-Number: K161853 · 2017-02-27

ApplicantAesculap, Inc.
Decision Date2017-02-27
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2017-02-27 under approval number K161853. 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 proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System?

proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System is a medical device that received FDA 510(k) clearance on 2017-02-27. It is manufactured by Aesculap, Inc.. The 510(k) number is K161853.

When was proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System approved by the FDA?

proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System received FDA 510(k) clearance on 2017-02-27, under approval number K161853.

What company makes proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System?

proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System is manufactured by Aesculap, Inc..

What is the FDA product code for proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System?

The FDA product code for proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System is JXG.

Related Clinical Trials

NCT07402239 HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management RECRUITING NCT05685303 Alleviant ALLAY-HF Study ENROLLING_BY_INVITATION NCT06812533 Alleviant ALLAY-HFrEF Study ENROLLING_BY_INVITATION NCT05199246 Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders COMPLETED

Other Devices by Aesculap, Inc.

K152960ELAN 4 Motor System K160393AdTec K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture K172850SterilContainer with PrimeLine Pro Lid K173271Aesculap Slim Clip Applier Forceps K171001Monosyn Quick Synthetic Absorbable Surgical Suture

View all 34 devices →

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences 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.

↑