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FDA 510(k)

Sterisystem Dry-Base Instrument Tray

K-Number: K203177 · 2022-01-02

ApplicantO&M Halyard, Inc.
Decision Date2022-01-02
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterisystem Dry-Base Instrument Tray is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2022-01-02 under 510(k) number K203177. 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 Sterisystem Dry-Base Instrument Tray?

Sterisystem Dry-Base Instrument Tray is a medical device that received FDA 510(k) clearance on 2022-01-02. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K203177.

When did Sterisystem Dry-Base Instrument Tray receive FDA 510(k) clearance?

Sterisystem Dry-Base Instrument Tray received FDA 510(k) clearance on 2022-01-02, under 510(k) number K203177.

Who is the listed applicant for Sterisystem Dry-Base Instrument Tray?

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

What is the FDA product code for Sterisystem Dry-Base Instrument Tray?

The FDA product code for Sterisystem Dry-Base Instrument Tray is KCT.

Other records listing O&M Halyard, 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.

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.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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