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swiftPro System SWF-SPS01

by Emblation Limited

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060652910213 UDI-DI Date8 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250718 Date8 Aug 2025DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
swiftPro System
Generic name
Microwave hyperthermia system
Model / Ref / Catalog
SWF-SPS01
Primary DI / UDI-DI
05060652910213
510(k) Number
FDA product code
NEY
GMDN term
Microwave hyperthermia system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K240518)

Cleared under the same submission (K250718)

Other devices from Emblation Limited

See all devices from Emblation Limited →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No