FDA.reportPublic FDA data

RESILIENCE™

Primary DI
00884450093627
Brand
RESILIENCE™
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
RE175
Published
2026-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251265000Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.2025-07-23ESW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450093627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450093627008844500936278844500936270884450093627

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450029695Merit Medical®Initial ReleaseK08-02207A2026-07-24
00884450383865Merit Medical®Initial ReleaseK10-01245L2026-07-25
00884450419922SureCrossDSC181352026-07-24
00884450428320Merit Medical®Initial ReleaseK09-10593C2026-07-24
00884450470831Merit Medical®Initial ReleaseK09-12157A2026-07-24
00884450484203Merit Medical®Initial ReleaseK09-144012026-07-24
00884450485569Merit Medical®Initial ReleaseK12T-127302026-07-24
00884450486214Merit Medical®Initial ReleaseK12T-12593A2026-07-24
00884450486955Merit Medical®Initial ReleaseK02-016512026-07-25
00884450545010Aspira®Initial Release49925242026-07-25
00884450545034Aspira®Initial Release4992524B2026-07-25
00884450793817BioFlo DuraMax®AH9651030380112026-07-25
00884450846148Merit Medical®Initial ReleaseK09-14237A2026-07-25
00884450433812Merit Medical®Initial ReleaseK08-02803A2026-07-23
00884450485163Merit Medical®Initial ReleaseK12T-11888B2026-07-23
00884450376546Merit Medical®Initial ReleaseK09-05229L2026-07-22
00884450431764Merit Medical®Initial ReleaseK10-04836A2026-07-22
00884450488751Merit Medical®Initial ReleaseK09-144102026-07-22
00884450492888Merit Medical®Initial ReleaseK01-08008A2026-07-22
00884450499276Merit Medical®Initial ReleaseK09-13679B2026-07-22

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
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
08800026631996HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22