510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252388Substantially Equivalent

Vanquish Water Vapor Ablation Device

Francis Medical, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252388 is the FDA 510(k) clearance record for Vanquish Water Vapor Ablation Device, a class II device, cleared for Francis Medical, Inc. on under FDA product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)). FDA records list one 510(k) clearance for Francis Medical, Inc. As of , FDA records show no recalls naming K252388.

Clearance record

Decision date
Received
(118 days to decision)
Product code
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Francis Medical, Inc. 7351 Kirkwood Ln. N, Suite 130, Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNS

Trailing 12 months
4 clearances under product code KNS in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KNS, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260