FDA.report

HILZO Esophageal stents

Primary DI
08809423568614
Brand
HILZO Esophageal stents
Company
BCM Co., Ltd.
Model
EVP1809HU1
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ESWProsthesis, Esophageal

Product Code Classifications

CodeDeviceSpecialtyClass
ESWProsthesis, EsophagealGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809423568614PrimaryGS10

GMDN Terms

TermDefinition
Polymer-metal oesophageal stentA non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g., anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.

Sterilization Methods

Method

Regulatory Flags

DUNS number
690134873
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800026631149HILZO Esophageal stentsEVP1806HU2026-01-29
08800026612711HILZO Esophageal stents EVP1906FC22026-01-22
08800026612728HILZO Esophageal stents EVP1907FC22026-01-22
08800026612735HILZO Esophageal stents EVP1908FC22026-01-22
08800026612742HILZO Esophageal stents EVP1909FC22026-01-22
08800026612759HILZO Esophageal stents EVP1910FC22026-01-22
08800026612766HILZO Esophageal stents EVP1911FC22026-01-22
08800026612773HILZO Esophageal stents EVP1912FC22026-01-22
08800026612780HILZO Esophageal stents EVP1913FC22026-01-22
08800026631156HILZO Esophageal stentsEVP1807HU2026-01-22
08800026631163HILZO Esophageal stentsEVP1808HU2026-01-22
08800026631170HILZO Esophageal stentsEVP1809HU2026-01-22
08800026631187HILZO Esophageal stentsEVP1810HU2026-01-22
08800026631194HILZO Esophageal stentsEVP1811HU2026-01-22
08800026631200HILZO Esophageal stentsEVP1812HU2026-01-22
08800026631217HILZO Esophageal stentsEVP1813HU2026-01-22
08800026631224HILZO Esophageal stentsEVP1814HU2026-01-22
08800026631231HILZO Esophageal stentsEVP1815HU2026-01-22
08800026631286HILZO Esophageal stentsEVP2006HU2026-01-22
08800026631293HILZO Esophageal stentsEVP2007HU2026-01-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800026631149HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-29
00884450093580RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093597RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093603RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093627RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093917RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094020RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094037RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094105RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094242RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
08800026612711HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612728HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612735HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612742HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612759HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612766HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612773HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612780HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026631156HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631163HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631170HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631187HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631194HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631200HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631217HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631224HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631231HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631286HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631293HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631989HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22