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FDA 510(k)

GFS Ultimate

K-Number: K162198 · 2016-11-18

ApplicantParcus Medical, LLC
Decision Date2016-11-18
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GFS Ultimate 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 2016-11-18 under 510(k) number K162198. 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 GFS Ultimate?

GFS Ultimate is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Parcus Medical, LLC. The 510(k) number is K162198.

When did GFS Ultimate receive FDA 510(k) clearance?

GFS Ultimate received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162198.

Who is the listed applicant for GFS Ultimate?

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 GFS Ultimate?

The FDA product code for GFS Ultimate is MBI.

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.

K232513X-Twist Biocomposite Suture AnchorK221502Parcus 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 Hip

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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.

K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.

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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