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FDA 510(k)

USGI SHAPELOCK ENDOSCOPIC GUIDE

K-Number: K050253 · 2005-02-28

ApplicantUsgi Medical
Decision Date2005-02-28
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

USGI SHAPELOCK ENDOSCOPIC GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Usgi Medical. It received FDA 510(k) clearance on 2005-02-28 under 510(k) number K050253. 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 SHAPELOCK ENDOSCOPIC GUIDE?

USGI SHAPELOCK ENDOSCOPIC GUIDE is a medical device that received FDA 510(k) clearance on 2005-02-28. The listed applicant is Usgi Medical. The 510(k) number is K050253.

When did USGI SHAPELOCK ENDOSCOPIC GUIDE receive FDA 510(k) clearance?

USGI SHAPELOCK ENDOSCOPIC GUIDE received FDA 510(k) clearance on 2005-02-28, under 510(k) number K050253.

Who is the listed applicant for USGI SHAPELOCK ENDOSCOPIC GUIDE?

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 SHAPELOCK ENDOSCOPIC GUIDE?

The FDA product code for USGI SHAPELOCK ENDOSCOPIC GUIDE 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 205333K072405USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE

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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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