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FDA 510(k)

MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS

K-Number: K093392 · 2009-12-31

Decision Date2009-12-31
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2009-12-31 under 510(k) number K093392. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS?

MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS is a medical device that received FDA 510(k) clearance on 2009-12-31. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K093392.

When did MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS receive FDA 510(k) clearance?

MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS received FDA 510(k) clearance on 2009-12-31, under 510(k) number K093392.

Who is the listed applicant for MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS?

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

What is the FDA product code for MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS?

The FDA product code for MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS is FGE.

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.

Other records listing Navilyst Medical, 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.

View all 25 devices →

Related Devices (Code: FGE)

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.

Official Source

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

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