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HYGEA Ease TMS15

by Hygea Medical Technology Co., Ltd.

HYGEA Ease TMS15 is a surgical ablation temperature probe (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by Hygea Medical Technology Co., Ltd., cleared under FDA 510(k) K243042 on 29 Jan 2025 and listed in FDA GUDID since 8 Sep 2025 (UDI-DI 06935650602066), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K243042

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06935650602066 UDI-DI Date8 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243042 Date29 Jan 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243042 decided 29 Jan 2025 Active
  • FDA GUDID UDI-DI 06935650602066 listed 8 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243042
  2. Listed FDA GUDID 06935650602066

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hygea
Generic name
Surgical ablation temperature probe
Model / reference
Ease TMS15
Primary DI / UDI-DI
06935650602066
510(k) Number
FDA product code
GEH
GMDN term
Surgical ablation temperature probe
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Cryosurgical system temperature probe

Cleared under the same submission (K243042)

and 8 more cleared under K243042

Similar devices

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

Other devices from Hygea Medical Technology Co., Ltd.

See all devices from Hygea Medical Technology Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)