Cleared Traditional

K252388 - Vanquish Water Vapor Ablation Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K252388 · Francis Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
118d
Days
Class 2
Risk

K252388 is an FDA 510(k) clearance for the Vanquish Water Vapor Ablation Device. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Francis Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on November 26, 2025 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Francis Medical, Inc. devices

Submission Details

510(k) Number K252388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2025
Decision Date November 26, 2025
Days to Decision 118 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 130d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

RQM+
Alexia Haralambous

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05683691 Active not recruiting Interventional Industry-sponsored

Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR

400
Patients (est.)
25
Sites
Treatment
Purpose
Open label
Masking
Condition studied Prostate Cancer
Study design Single group
Eligibility Male only · 50 Years+
Sponsor Francis Medical Inc. (industry)
Started 2023-05-16 → Primary completion 2027-04-01 → Completed 2029-04-01
Primary outcome
Primary Effectiveness Endpoint
Secondary outcome
Key Secondary Endpoint
View full study on ClinicalTrials.gov

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 186
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K252388.
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K252889 · Olympus Medical Systems Corporation · Nov 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
K250945 · Olympus Medical Systems Corp. · Oct 2025
Single Use Electrosurgical Knife (KD-612L, KD-612U)
K250351 · Olympus Medical Systems Corporation · Oct 2025
SureTome™ SW Sphincterotome with DomeTip
K251104 · Wilson Cook Medical · Sep 2025
Aqua Medical RF Vapor Ablation System
K251226 · Aqua Medical, Inc. · Aug 2025
Rezum System
K250584 · Boston Scientific Corporation · Jun 2025