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FDA 510(k)

Parcus GFS BTB

K-Number: K183331 · 2019-02-07

ApplicantParcus Medical, LLC
Decision Date2019-02-07
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Parcus GFS BTB 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 2019-02-07 under 510(k) number K183331. 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 GFS BTB?

Parcus GFS BTB is a medical device that received FDA 510(k) clearance on 2019-02-07. The listed applicant is Parcus Medical, LLC. The 510(k) number is K183331.

When did Parcus GFS BTB receive FDA 510(k) clearance?

Parcus GFS BTB received FDA 510(k) clearance on 2019-02-07, under 510(k) number K183331.

Who is the listed applicant for Parcus GFS BTB?

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 GFS BTB?

The FDA product code for Parcus GFS BTB 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.

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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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.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.

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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