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FDA 510(k)

FINESS ENDOSCOPE STERILIZATION TRAY

K-Number: K103213 · 2011-02-02

ApplicantEntellus Medical, Inc.
Decision Date2011-02-02
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FINESS ENDOSCOPE STERILIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Entellus Medical, Inc.. It received FDA 510(k) clearance on 2011-02-02 under 510(k) number K103213. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINESS ENDOSCOPE STERILIZATION TRAY?

FINESS ENDOSCOPE STERILIZATION TRAY is a medical device that received FDA 510(k) clearance on 2011-02-02. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K103213.

When did FINESS ENDOSCOPE STERILIZATION TRAY receive FDA 510(k) clearance?

FINESS ENDOSCOPE STERILIZATION TRAY received FDA 510(k) clearance on 2011-02-02, under 510(k) number K103213.

Who is the listed applicant for FINESS ENDOSCOPE STERILIZATION TRAY?

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

What is the FDA product code for FINESS ENDOSCOPE STERILIZATION TRAY?

The FDA product code for FINESS ENDOSCOPE STERILIZATION TRAY is KCT.

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Other records listing Entellus Medical, Inc. as applicant

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Related Devices (Code: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, 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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