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FDA 510(k)

POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM

K-Number: K012105 · 2002-08-02

ApplicantSymmetry Medical, Inc.
Decision Date2002-08-02
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Symmetry Medical, Inc.. It received FDA 510(k) clearance on 2002-08-02 under 510(k) number K012105. 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 POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM?

POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2002-08-02. The listed applicant is Symmetry Medical, Inc.. The 510(k) number is K012105.

When did POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM receive FDA 510(k) clearance?

POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM received FDA 510(k) clearance on 2002-08-02, under 510(k) number K012105.

Who is the listed applicant for POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM?

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

What is the FDA product code for POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM?

The FDA product code for POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 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

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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