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FDA 510(k)

FOSSA URETERAL OPEN LUMEN STENT

K-Number: K033368 · 2003-11-26

ApplicantFossa Medical, Inc.
Decision Date2003-11-26
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOSSA URETERAL OPEN LUMEN STENT is the device name listed in this FDA 510(k) record. The listed applicant is Fossa Medical, Inc.. It received FDA 510(k) clearance on 2003-11-26 under 510(k) number K033368. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOSSA URETERAL OPEN LUMEN STENT?

FOSSA URETERAL OPEN LUMEN STENT is a medical device that received FDA 510(k) clearance on 2003-11-26. The listed applicant is Fossa Medical, Inc.. The 510(k) number is K033368.

When did FOSSA URETERAL OPEN LUMEN STENT receive FDA 510(k) clearance?

FOSSA URETERAL OPEN LUMEN STENT received FDA 510(k) clearance on 2003-11-26, under 510(k) number K033368.

Who is the listed applicant for FOSSA URETERAL OPEN LUMEN STENT?

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

What is the FDA product code for FOSSA URETERAL OPEN LUMEN STENT?

The FDA product code for FOSSA URETERAL OPEN LUMEN STENT is EYB.

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.

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Other records listing Fossa 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.

K072293FOSSA URETERAL OPEN STENTSK031292MODIFICATION TO FOSSA URETERAL STONE SWEEPER

Related Devices (Code: EYB)

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.

K192183RocaTub Ureteral CatheterPromepal SamK191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.K183323UPJ Occlusion Balloon CatheterCook IncorporatedK182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook IncorporatedK182122Ureteric CathetersColoplast Corp.K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated

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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