Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WILSON-COOK COLONIC Z-STENT

K-Number: K990034 · 2000-04-17

ApplicantMed Institute, Inc.
Decision Date2000-04-17
Product CodeMQR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WILSON-COOK COLONIC Z-STENT is the device name listed in this FDA 510(k) record. The listed applicant is Med Institute, Inc.. It received FDA 510(k) clearance on 2000-04-17 under 510(k) number K990034. 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 WILSON-COOK COLONIC Z-STENT?

WILSON-COOK COLONIC Z-STENT is a medical device that received FDA 510(k) clearance on 2000-04-17. The listed applicant is Med Institute, Inc.. The 510(k) number is K990034.

When did WILSON-COOK COLONIC Z-STENT receive FDA 510(k) clearance?

WILSON-COOK COLONIC Z-STENT received FDA 510(k) clearance on 2000-04-17, under 510(k) number K990034.

Who is the listed applicant for WILSON-COOK COLONIC Z-STENT?

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

What is the FDA product code for WILSON-COOK COLONIC Z-STENT?

The FDA product code for WILSON-COOK COLONIC Z-STENT is MQR.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Med Institute, 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.

K982507MINI POLYURETHANE CATHETERK981061INTRAVASCULAR RETRIEVAL DEVICEK964001SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEMK971140VITAL-PORT INFUSION PALK970442TARGET VITAL-PORT VASCULAR ACCESS SYSTEMK945586FLEXIBLE DILATING SHEATH

View all 26 devices →

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.

↑