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FDA 510(k)

Pivot System Sterilization case

K-Number: K181845 · 2019-11-25

ApplicantRp Medical, Inc.
Decision Date2019-11-25
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Pivot System Sterilization case is the device name listed in this FDA 510(k) record. The listed applicant is Rp Medical, Inc.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K181845. 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 Pivot System Sterilization case?

Pivot System Sterilization case is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Rp Medical, Inc.. The 510(k) number is K181845.

When did Pivot System Sterilization case receive FDA 510(k) clearance?

Pivot System Sterilization case received FDA 510(k) clearance on 2019-11-25, under 510(k) number K181845.

Who is the listed applicant for Pivot System Sterilization case?

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

What is the FDA product code for Pivot System Sterilization case?

The FDA product code for Pivot System Sterilization case 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.

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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