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FDA 510(k)

SIPHONX GRAVITATIONAL ANTISIPHON DEVICE

K-Number: K091328 · 2010-01-22

ApplicantSophysa SA
Decision Date2010-01-22
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SIPHONX GRAVITATIONAL ANTISIPHON DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa SA. It received FDA 510(k) clearance on 2010-01-22 under 510(k) number K091328. 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 SIPHONX GRAVITATIONAL ANTISIPHON DEVICE?

SIPHONX GRAVITATIONAL ANTISIPHON DEVICE is a medical device that received FDA 510(k) clearance on 2010-01-22. The listed applicant is Sophysa SA. The 510(k) number is K091328.

When did SIPHONX GRAVITATIONAL ANTISIPHON DEVICE receive FDA 510(k) clearance?

SIPHONX GRAVITATIONAL ANTISIPHON DEVICE received FDA 510(k) clearance on 2010-01-22, under 510(k) number K091328.

Who is the listed applicant for SIPHONX GRAVITATIONAL ANTISIPHON DEVICE?

The FDA 510(k) record lists Sophysa SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIPHONX GRAVITATIONAL ANTISIPHON DEVICE?

The FDA product code for SIPHONX GRAVITATIONAL ANTISIPHON DEVICE is JXG.

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Other records listing Sophysa SA 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.

K162108Pressio 2 ICP Monitoring SystemK090342POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400K062584PRESSIO ICP MONITORING SYSTEMK042481POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400K031097POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVBK013488SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

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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.

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 CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra 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.

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