510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222304Substantially Equivalent

Sonata Transcervical Fibroid Ablation System 2.2

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

K222304 is the FDA 510(k) clearance record for Sonata Transcervical Fibroid Ablation System 2.2, a class II device, cleared for Gynesonics, Inc. on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list 8 510(k) clearances for Gynesonics, Inc., from to . As of , FDA records show no recalls naming K222304.

Clearance record

Decision date
Received
(99 days to decision)
Product code
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gynesonics, Inc. 600 Chesapeake Dr., Redwood City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNF

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