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FDA 510(k)

MITEK PDS/PGA STAPLE

K-Number: K021953 · 2002-12-20

ApplicantMitek Worldwide
Decision Date2002-12-20
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MITEK PDS/PGA STAPLE is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Worldwide. It received FDA 510(k) clearance on 2002-12-20 under 510(k) number K021953. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITEK PDS/PGA STAPLE?

MITEK PDS/PGA STAPLE is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Mitek Worldwide. The 510(k) number is K021953.

When did MITEK PDS/PGA STAPLE receive FDA 510(k) clearance?

MITEK PDS/PGA STAPLE received FDA 510(k) clearance on 2002-12-20, under 510(k) number K021953.

Who is the listed applicant for MITEK PDS/PGA STAPLE?

The FDA 510(k) record lists Mitek Worldwide as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MITEK PDS/PGA STAPLE?

The FDA product code for MITEK PDS/PGA STAPLE is JDR.

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Other records listing Mitek Worldwide as applicant

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.

K032717BIOCRYL RAPIDE INTERFERENCE SCREWK032167BIO-INTRAFIX TIBIAL SCREW AND SHEATHK032078MITEK MICRO QUICKANCHORK030995MINILOK QUICKANCHOR PLUSK031519CUFFLOK ANCHORK031406EXOJET TISSUE MANAGEMENT SYSTEM

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Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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