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FDA 510(k)

G-CINCH SUTURE GRASPER

K-Number: K102931 · 2010-12-30

ApplicantUsgi Medical
Decision Date2010-12-30
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

G-CINCH SUTURE GRASPER is the device name listed in this FDA 510(k) record. The listed applicant is Usgi Medical. It received FDA 510(k) clearance on 2010-12-30 under 510(k) number K102931. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-CINCH SUTURE GRASPER?

G-CINCH SUTURE GRASPER is a medical device that received FDA 510(k) clearance on 2010-12-30. The listed applicant is Usgi Medical. The 510(k) number is K102931.

When did G-CINCH SUTURE GRASPER receive FDA 510(k) clearance?

G-CINCH SUTURE GRASPER received FDA 510(k) clearance on 2010-12-30, under 510(k) number K102931.

Who is the listed applicant for G-CINCH SUTURE GRASPER?

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-CINCH SUTURE GRASPER?

The FDA product code for G-CINCH SUTURE GRASPER is OCW.

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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 GRASPERK102916G-CATH TISSUE ANCHOR DELIVERY CATHETERK100251G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333K093018G-PROX ENDOSCOPIC GRASPER, MODEL 205333K072405USGI TRANSPORT ENDOSCOPIC ACCESS DEVICEK061276G-PROX ENDOSCOPIC GRASPER

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Related Devices (Code: OCW)

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.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

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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