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FDA 510(k)

USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE

K-Number: K072405 · 2007-09-13

ApplicantUsgi Medical
Decision Date2007-09-13
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Usgi Medical. It received FDA 510(k) clearance on 2007-09-13 under 510(k) number K072405. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE?

USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 2007-09-13. The listed applicant is Usgi Medical. The 510(k) number is K072405.

When did USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE receive FDA 510(k) clearance?

USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE received FDA 510(k) clearance on 2007-09-13, under 510(k) number K072405.

Who is the listed applicant for USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE?

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 USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE?

The FDA product code for USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE is FED.

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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 205333K061276G-PROX ENDOSCOPIC GRASPER

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Related Devices (Code: FED)

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.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific CorporationK260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

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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