510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253826Substantially Equivalent

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle

Galvanize Therapeutics, Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253826 is the FDA 510(k) clearance record for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle, a class II device, cleared for Galvanize Therapeutics, Inc. on under FDA product code OAB (Low Energy Direct Current Thermal Ablation System). FDA's definition for product code OAB reads: "Ablation of soft tissue". FDA records list 3 510(k) clearances for Galvanize Therapeutics, Inc., from to . As of , FDA records show no recalls naming K253826.

Clearance record

Decision date
Received
(157 days to decision)
Product code
OAB Low Energy Direct Current Thermal Ablation System
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Galvanize Therapeutics, Inc. 3200 Bridge Pkwy., Redwood City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAB

Trailing 12 months
3 clearances under product code OAB in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OAB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260