FDA.reportPublic FDA data

Vanquish Water Vapor Ablation System

Primary DI
00850050904045
Brand
Vanquish Water Vapor Ablation System
Company
Francis Medical, Inc.
Model
5257-001
Device description
Delivery Device, RTX
Published
2026-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252388000Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.2025-11-26KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050904045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050904045008500509040458500509040450850050904045

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic navigation/ultrasound-guided transurethral prostate water vapour ablation systemAn assembly of devices intended to be used for the thermal ablation of targeted prostate tissue using water vapour via a transurethral approach under ultrasound guidance. It includes: 1) a water vapour ablation generator/control unit; 2) an invasive water vapour delivery device (e.g., needle/catheter); and 3) an electromagnetic field generator with an imaging workstation for navigation to aid needle guidance to targeted prostate tissue. Carts, holders, cradles, and accessories may be supplied as part of the system.

Regulatory Flags#

DUNS number
081278677
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050904007Vanquish Water Vapor Ablation System4570-0012026-06-30
00850050904014Vanquish Water Vapor Ablation System4571-0012026-06-30
00850050904021Vanquish Water Vapor Ablation System4572-0012026-06-30
00850050904038Vanquish Water Vapor Ablation System4573-0012026-06-30
00850050904052Vanquish Water Vapor Ablation System5245-0012026-06-30
00850050904069Vanquish Water Vapor Ablation System4751-0012026-06-30
00850050904076Vanquish Water Vapor Ablation System4752-0012026-06-30
00850050904083Vanquish Water Vapor Ablation System4741-0012026-06-30
00850050904090Vanquish Water Vapor Ablation System4839-0012026-06-30
00850050904106Vanquish Water Vapor Ablation System4840-0012026-06-30
00850050904113Vanquish Water Vapor Ablation System5536-0012026-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060359561404Speedboat Ultraslim LongCREO MEDICAL LIMITEDKNS2026-10-01
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05060359561480Speedboat Notch LongCREO MEDICAL LIMITEDKNS2026-10-01
05060359561527Speedboat Notch ShortCREO MEDICAL LIMITEDKNS2026-10-01
05060359561565SpydrBlade FlexCREO MEDICAL LIMITEDKNS2026-10-01
05060359561602FootswitchCREO MEDICAL LIMITEDKNS2026-10-01
05060359561626Reusable Interface Cable, 1.5 mCREO MEDICAL LIMITEDKNS2026-10-01
06959664901069NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901076NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901595NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
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06959664902646NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
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06959664910498NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910559NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910566NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910597NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910764NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911921NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
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06959664911983NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911990NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912041NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912065NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912072NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912089NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
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