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FDA 510(k)

ENDOFLIP ECD

K-Number: K110531 · 2011-10-06

ApplicantCrospon, Ltd.
Decision Date2011-10-06
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOFLIP ECD is the device name listed in this FDA 510(k) record. The listed applicant is Crospon, Ltd.. It received FDA 510(k) clearance on 2011-10-06 under 510(k) number K110531. 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 ENDOFLIP ECD?

ENDOFLIP ECD is a medical device that received FDA 510(k) clearance on 2011-10-06. The listed applicant is Crospon, Ltd.. The 510(k) number is K110531.

When did ENDOFLIP ECD receive FDA 510(k) clearance?

ENDOFLIP ECD received FDA 510(k) clearance on 2011-10-06, under 510(k) number K110531.

Who is the listed applicant for ENDOFLIP ECD?

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

What is the FDA product code for ENDOFLIP ECD?

The FDA product code for ENDOFLIP ECD is FED.

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Other records listing Crospon, 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.

K183072EndoFLIP SystemK172128EsoFLIP® ES-310 Balloon CatheterK170833EndoFLIP® System with FLIP Topography moduleK160725EndoFLIPK132337ESOFLIP BALLOON DILATION CATHETERK130906ENDOFLIP CATHETER

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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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