510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243042Substantially Equivalent

Co-Ablation System with Sterile Co-Ablation Probe

Hygea Medical Technology Co., Ltd., Beijing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243042 is the FDA 510(k) clearance record for Co-Ablation System with Sterile Co-Ablation Probe, a class II device, cleared for Hygea Medical Technology Co., Ltd. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 2 510(k) clearances for Hygea Medical Technology Co., Ltd., from to . As of , FDA records show no recalls naming K243042.

Clearance record

Decision date
Received
(124 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Hygea Medical Technology Co., Ltd. Floor 6&7, W. Area Of Bldg. # 8, #30 Yuhua Rd.,, Beijing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260