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FDA 510(k)

RAINS FRONTAL SINUS STENT

K-Number: K951066 · 1995-04-04

ApplicantSmith & Nephew Richards, Inc.
Decision Date1995-04-04
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RAINS FRONTAL SINUS STENT is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1995-04-04 under 510(k) number K951066. The device is classified under product code KAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAINS FRONTAL SINUS STENT?

RAINS FRONTAL SINUS STENT is a medical device that received FDA 510(k) clearance on 1995-04-04. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K951066.

When did RAINS FRONTAL SINUS STENT receive FDA 510(k) clearance?

RAINS FRONTAL SINUS STENT received FDA 510(k) clearance on 1995-04-04, under 510(k) number K951066.

Who is the listed applicant for RAINS FRONTAL SINUS STENT?

The FDA 510(k) record lists Smith & Nephew Richards, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAINS FRONTAL SINUS STENT?

The FDA product code for RAINS FRONTAL SINUS STENT is KAM.

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Other records listing Smith & Nephew Richards, 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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP SYSTEM

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Related Devices (Code: KAM)

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.

K110687RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)Acclarent, Inc.K093594MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K083574RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K072891SINUS SPACERAcclarent, Inc.K073041RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETERAcclarent, Inc.K071845RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AAcclarent, Inc.

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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