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FDA 510(k)

WALLSTENT ENTERAL ENDOPROSTHESIS

K-Number: K980113 · 1998-04-03

ApplicantBoston Scientific Scimed, Inc.
Decision Date1998-04-03
Product CodeMUM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WALLSTENT ENTERAL ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Scimed, Inc.. It received FDA 510(k) clearance on 1998-04-03 under 510(k) number K980113. The device is classified under product code MUM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLSTENT ENTERAL ENDOPROSTHESIS?

WALLSTENT ENTERAL ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K980113.

When did WALLSTENT ENTERAL ENDOPROSTHESIS receive FDA 510(k) clearance?

WALLSTENT ENTERAL ENDOPROSTHESIS received FDA 510(k) clearance on 1998-04-03, under 510(k) number K980113.

Who is the listed applicant for WALLSTENT ENTERAL ENDOPROSTHESIS?

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

What is the FDA product code for WALLSTENT ENTERAL ENDOPROSTHESIS?

The FDA product code for WALLSTENT ENTERAL ENDOPROSTHESIS is MUM.

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Other records listing Boston Scientific Scimed, 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.

K041727MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456K030617PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIREK024048MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEMK021735BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETERK021901WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMK012822MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX

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Related Devices (Code: MUM)

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.

K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredCook Ireland, Ltd.K101530EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-DCook Ireland, Ltd.K062750WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030Boston Scientific Corp

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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