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FDA 510(k)

COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE

K-Number: K091016 · 2009-05-04

ApplicantSurgical Devices, A Global Business Unit Covidien
Decision Date2009-05-04
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Devices, A Global Business Unit Covidien. It received FDA 510(k) clearance on 2009-05-04 under 510(k) number K091016. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE?

COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE is a medical device that received FDA 510(k) clearance on 2009-05-04. The listed applicant is Surgical Devices, A Global Business Unit Covidien. The 510(k) number is K091016.

When did COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE receive FDA 510(k) clearance?

COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE received FDA 510(k) clearance on 2009-05-04, under 510(k) number K091016.

Who is the listed applicant for COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE?

The FDA 510(k) record lists Surgical Devices, A Global Business Unit Covidien as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE?

The FDA product code for COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE is GAT.

Related Clinical Trials

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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Other records listing Surgical Devices, A Global Business Unit Covidien 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.

K083781EEA HEMORRHOID STAPLER & ACCESSORIESK082535COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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