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Smtp XDF0980115

by SMTP Medical Co., Ltd.

Smtp XDF0980115 is a Class II device made by SMTP Medical Co., Ltd., cleared under FDA 510(k) K201274 on 19 Feb 2021 and listed in FDA GUDID since 15 Aug 2023 (UDI-DI 06972603519040), 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) K201274

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 Number06972603519040 UDI-DI Date15 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201274 Date19 Feb 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201274 decided 19 Feb 2021 Active
  • FDA GUDID UDI-DI 06972603519040 listed 15 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201274
  2. Listed FDA GUDID 06972603519040

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Smtp
Generic name
Ultrasonic surgical system handpiece cooling sleeve
Model / reference
XDF0980115
Description
Liquid-flow sleeve (hard)
Primary DI / UDI-DI
06972603519040
FDA product code
JDX
GMDN term
Ultrasonic surgical system handpiece cooling sleeve
Device class
Class II
Regulation number
888.4580
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Related devices

Category: Ultrasonic surgical system handpiece cooling sleeve

Cleared under the same submission (K201274)

and 8 more cleared under K201274

Similar devices

Other devices filed under FDA product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment).

Other devices from SMTP Medical Co., Ltd.

See all devices from SMTP Medical Co., Ltd. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)