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FDA 510(k)

FRONTAL SINUS TREPHINATION CANNULA

K-Number: K994262 · 2000-02-08

ApplicantXomed, Inc.
Decision Date2000-02-08
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRONTAL SINUS TREPHINATION CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 2000-02-08 under 510(k) number K994262. 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 FRONTAL SINUS TREPHINATION CANNULA?

FRONTAL SINUS TREPHINATION CANNULA is a medical device that received FDA 510(k) clearance on 2000-02-08. The listed applicant is Xomed, Inc.. The 510(k) number is K994262.

When did FRONTAL SINUS TREPHINATION CANNULA receive FDA 510(k) clearance?

FRONTAL SINUS TREPHINATION CANNULA received FDA 510(k) clearance on 2000-02-08, under 510(k) number K994262.

Who is the listed applicant for FRONTAL SINUS TREPHINATION CANNULA?

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

What is the FDA product code for FRONTAL SINUS TREPHINATION CANNULA?

The FDA product code for FRONTAL SINUS TREPHINATION CANNULA is KAM.

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Other records listing Xomed, 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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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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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