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FDA 510(k)

THE ULTRA

K-Number: K935755 · 1995-05-05

ApplicantMedical Device Systems, Inc.
Decision Date1995-05-05
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Systems, Inc.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K935755. 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 THE ULTRA?

THE ULTRA is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Medical Device Systems, Inc.. The 510(k) number is K935755.

When did THE ULTRA receive FDA 510(k) clearance?

THE ULTRA received FDA 510(k) clearance on 1995-05-05, under 510(k) number K935755.

Who is the listed applicant for THE ULTRA?

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

What is the FDA product code for THE ULTRA?

The FDA product code for THE ULTRA is KCT.

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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

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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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