FDA.reportPublic FDA data

HILZO Esophageal stents

Primary DI
08809423568485
Brand
HILZO Esophageal stents
Company
BCM Co., Ltd.
Model
EVP2006HCS2-I
Published
2026-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ESWProsthesis, Esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESWProsthesis, EsophagealGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809423568485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809423568485088094235684858809423568485

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
690134873
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
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