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FDA 510(k)

ARC ENDOCUFF

K-Number: K122565 · 2012-09-04

ApplicantBoddingtons Plastics, Ltd.
Decision Date2012-09-04
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ARC ENDOCUFF is the device name listed in this FDA 510(k) record. The listed applicant is Boddingtons Plastics, Ltd.. It received FDA 510(k) clearance on 2012-09-04 under 510(k) number K122565. 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 ARC ENDOCUFF?

ARC ENDOCUFF is a medical device that received FDA 510(k) clearance on 2012-09-04. The listed applicant is Boddingtons Plastics, Ltd.. The 510(k) number is K122565.

When did ARC ENDOCUFF receive FDA 510(k) clearance?

ARC ENDOCUFF received FDA 510(k) clearance on 2012-09-04, under 510(k) number K122565.

Who is the listed applicant for ARC ENDOCUFF?

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

What is the FDA product code for ARC ENDOCUFF?

The FDA product code for ARC ENDOCUFF is FED.

Related Clinical Trials

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Other records listing Boddingtons Plastics, Ltd. 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.

K191330Arc EnterocuffK191067Arc Endocuff Glide AEG110 & AEG120K162205Arc EndoCuff and Arc EndoCuff Vision

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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