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FDA 510(k)

NDO SURGICAL SURGICAL OVERTUBE

K-Number: K002018 · 2000-08-17

ApplicantSurgical, Inc.
Decision Date2000-08-17
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NDO SURGICAL SURGICAL OVERTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical, Inc.. It received FDA 510(k) clearance on 2000-08-17 under 510(k) number K002018. 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 NDO SURGICAL SURGICAL OVERTUBE?

NDO SURGICAL SURGICAL OVERTUBE is a medical device that received FDA 510(k) clearance on 2000-08-17. The listed applicant is Surgical, Inc.. The 510(k) number is K002018.

When did NDO SURGICAL SURGICAL OVERTUBE receive FDA 510(k) clearance?

NDO SURGICAL SURGICAL OVERTUBE received FDA 510(k) clearance on 2000-08-17, under 510(k) number K002018.

Who is the listed applicant for NDO SURGICAL SURGICAL OVERTUBE?

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

What is the FDA product code for NDO SURGICAL SURGICAL OVERTUBE?

The FDA product code for NDO SURGICAL SURGICAL OVERTUBE is FED.

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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

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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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