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HYGEA Ease TML15A

by Hygea Medical Technology Co., Ltd.

HYGEA Ease TML15A is a microwave ablation system generator (FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Hygea Medical Technology Co., Ltd., cleared under FDA 510(k) K233140 on 31 Jan 2024 and listed in FDA GUDID since 8 Sep 2025 (UDI-DI 06935650626451), 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) K233140

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 Number06935650626451 UDI-DI Date8 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233140 Date31 Jan 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233140 decided 31 Jan 2024 Active
  • FDA GUDID UDI-DI 06935650626451 listed 8 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233140
  2. Listed FDA GUDID 06935650626451

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  • Withdrawn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
Microwave ablation system generator
Model / reference
Ease TML15A
Primary DI / UDI-DI
06935650626451
510(k) Number
FDA product code
NEY
GMDN term
Microwave ablation system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Microwave ablation system generator

Cleared under the same submission (K233140)

and 8 more cleared under K233140

Similar devices

Other devices filed under FDA product code NEY (System, Ablation, Microwave And 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)