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FDA 510(k)

G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333

K-Number: K100251 · 2010-02-17

ApplicantUsgi Medical
Decision Date2010-02-17
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 is the device name listed in this FDA 510(k) record. The listed applicant is Usgi Medical. It received FDA 510(k) clearance on 2010-02-17 under 510(k) number K100251. 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 G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333?

G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 is a medical device that received FDA 510(k) clearance on 2010-02-17. The listed applicant is Usgi Medical. The 510(k) number is K100251.

When did G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 receive FDA 510(k) clearance?

G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 received FDA 510(k) clearance on 2010-02-17, under 510(k) number K100251.

Who is the listed applicant for G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333?

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

What is the FDA product code for G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333?

The FDA product code for G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 is GAT.

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Other records listing Usgi Medical 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.

K103688G-PROX EZ ENDOSCOPIC GRASPERK102931G-CINCH SUTURE GRASPERK102916G-CATH TISSUE ANCHOR DELIVERY CATHETERK093018G-PROX ENDOSCOPIC GRASPER, MODEL 205333K072405USGI TRANSPORT ENDOSCOPIC ACCESS DEVICEK061276G-PROX ENDOSCOPIC GRASPER

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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

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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