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Sonicure TG-A

by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Sonicure TG-A is a device classified as Unclassified made by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., cleared under FDA 510(k) K212614 on 18 Jul 2022 and listed in FDA GUDID since 26 Oct 2022 (UDI-DI 16972304752828), active as of 23 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 23 Oct 2026

Documents

510(k) K212614

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16972304752828 UDI-DI Date26 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212614 Date18 Jul 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212614 decided 18 Jul 2022 Active
  • FDA GUDID UDI-DI 16972304752828 listed 26 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212614
  2. Listed FDA GUDID 16972304752828

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sonicure
Generic name
Foot-switch, electrical
Model / reference
TG-A
Primary DI / UDI-DI
16972304752828
510(k) Number
FDA product code
LFL
GMDN term
Foot-switch, electrical
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: Foot-switch, electrical

Cleared under the same submission (K212614)

and 2 more cleared under K212614

Similar devices in this category

Other devices filed under Foot-switch, electrical.

Other devices from Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

See all devices from Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)