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FDA 510(k)

SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE

K-Number: K023902 · 2003-08-20

ApplicantUsgi Medical, Inc.
Decision Date2003-08-20
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Usgi Medical, Inc.. It received FDA 510(k) clearance on 2003-08-20 under 510(k) number K023902. 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 SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE?

SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE is a medical device that received FDA 510(k) clearance on 2003-08-20. The listed applicant is Usgi Medical, Inc.. The 510(k) number is K023902.

When did SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE receive FDA 510(k) clearance?

SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE received FDA 510(k) clearance on 2003-08-20, under 510(k) number K023902.

Who is the listed applicant for SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE?

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

What is the FDA product code for SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE?

The FDA product code for SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE is FED.

Related Clinical Trials

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.

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Other records listing Usgi Medical, Inc. 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.

K033954SHAPE LOCKING ENDOSCOPIC OVERTUBE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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