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FDA 510(k)

URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK

K-Number: K093653 · 2010-02-23

ApplicantUresil, LLC
Decision Date2010-02-23
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK is the device name listed in this FDA 510(k) record. The listed applicant is Uresil, LLC. It received FDA 510(k) clearance on 2010-02-23 under 510(k) number K093653. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK?

URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK is a medical device that received FDA 510(k) clearance on 2010-02-23. The listed applicant is Uresil, LLC. The 510(k) number is K093653.

When did URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK receive FDA 510(k) clearance?

URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK received FDA 510(k) clearance on 2010-02-23, under 510(k) number K093653.

Who is the listed applicant for URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK?

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

What is the FDA product code for URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK?

The FDA product code for URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK is KNT.

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Official Source

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