FDA 510(k)

S.C.O.R.E.S. UNIT

K-Number: K110898 · 2012-07-26

Decision Date2012-07-26

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

S.C.O.R.E.S. UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Ammed Surgical Equipment, LLC. It received FDA 510(k) clearance on 2012-07-26 under 510(k) number K110898. 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 S.C.O.R.E.S. UNIT?

S.C.O.R.E.S. UNIT is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Ammed Surgical Equipment, LLC. The 510(k) number is K110898.

When did S.C.O.R.E.S. UNIT receive FDA 510(k) clearance?

S.C.O.R.E.S. UNIT received FDA 510(k) clearance on 2012-07-26, under 510(k) number K110898.

Who is the listed applicant for S.C.O.R.E.S. UNIT?

The FDA 510(k) record lists Ammed Surgical Equipment, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S.C.O.R.E.S. UNIT?

The FDA product code for S.C.O.R.E.S. UNIT is KCT.

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 AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K252854SteriTite 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.