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FDA 510(k)

PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR

K-Number: K122805 · 2013-02-05

ApplicantParcus Medical, LLC
Decision Date2013-02-05
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical, LLC. It received FDA 510(k) clearance on 2013-02-05 under 510(k) number K122805. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR?

PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2013-02-05. The listed applicant is Parcus Medical, LLC. The 510(k) number is K122805.

When did PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR receive FDA 510(k) clearance?

PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR received FDA 510(k) clearance on 2013-02-05, under 510(k) number K122805.

Who is the listed applicant for PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR?

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

What is the FDA product code for PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR?

The FDA product code for PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR is MBI.

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Other records listing Parcus Medical, 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.

K221502Parcus Synd-EZ SSK221135X-Twist PEEK Suture AnchorK212739ActiFlipK202662Parcus Titanium Interference ScrewsK202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate HipK201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors

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Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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