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FDA 510(k)

ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380

K-Number: K060323 · 2006-05-12

ApplicantBoston Scientific Corporation
Decision Date2006-05-12
Product CodeMQR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2006-05-12 under 510(k) number K060323. The device is classified under product code MQR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380?

ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 is a medical device that received FDA 510(k) clearance on 2006-05-12. The listed applicant is Boston Scientific Corporation. The 510(k) number is K060323.

When did ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 receive FDA 510(k) clearance?

ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 received FDA 510(k) clearance on 2006-05-12, under 510(k) number K060323.

Who is the listed applicant for ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380?

The FDA product code for ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 is MQR.

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Related Devices (Code: MQR)

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.

K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemBoston Scientific CorporationK201159WallFlex Colonic Stent System with Anchor Lock Delivery SystemBoston Scientific CorporationK200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemBoston Scientific CorporationK190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd.K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech 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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