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FDA 510(k)

G-LIX TISSUE GRASPER

K-Number: K061268 · 2006-07-31

ApplicantUsgi Medical
Decision Date2006-07-31
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

G-LIX TISSUE 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 2006-07-31 under 510(k) number K061268. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-LIX TISSUE GRASPER?

G-LIX TISSUE GRASPER is a medical device that received FDA 510(k) clearance on 2006-07-31. The listed applicant is Usgi Medical. The 510(k) number is K061268.

When did G-LIX TISSUE GRASPER receive FDA 510(k) clearance?

G-LIX TISSUE GRASPER received FDA 510(k) clearance on 2006-07-31, under 510(k) number K061268.

Who is the listed applicant for G-LIX TISSUE 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-LIX TISSUE GRASPER?

The FDA product code for G-LIX TISSUE GRASPER is HET.

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

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Related Devices (Code: HET)

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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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