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FDA 510(k)

Stealth Staple System

K-Number: K163440 · 2017-02-01

ApplicantFirst Ray, LLC
Decision Date2017-02-01
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stealth Staple System is the device name listed in this FDA 510(k) record. The listed applicant is First Ray, LLC. It received FDA 510(k) clearance on 2017-02-01 under 510(k) number K163440. 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 Stealth Staple System?

Stealth Staple System is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is First Ray, LLC. The 510(k) number is K163440.

When did Stealth Staple System receive FDA 510(k) clearance?

Stealth Staple System received FDA 510(k) clearance on 2017-02-01, under 510(k) number K163440.

Who is the listed applicant for Stealth Staple System?

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

What is the FDA product code for Stealth Staple System?

The FDA product code for Stealth Staple System is JDR.

Other records listing First Ray, LLC 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.

K153585Flip Button Suture AnchorK153638Bicortical Fixation Screw & Washer Nut SystemK153622First Ray Internal Bone Staple System

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.

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 ConceptsK242415TMC 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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