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FDA 510(k)

COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT

K-Number: K945201 · 1995-01-04

ApplicantCook, Inc.
Decision Date1995-01-04
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1995-01-04 under 510(k) number K945201. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT?

COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT is a medical device that received FDA 510(k) clearance on 1995-01-04. The listed applicant is Cook, Inc.. The 510(k) number is K945201.

When did COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT receive FDA 510(k) clearance?

COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT received FDA 510(k) clearance on 1995-01-04, under 510(k) number K945201.

Who is the listed applicant for COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT?

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

What is the FDA product code for COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT?

The FDA product code for COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT is ESW.

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Other records listing Cook, 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.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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Related Devices (Code: ESW)

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.

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific CorporationK243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston ScientificK233837Agile Esophageal Stent SystemBoston Scientific Corporation

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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