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Epimed 296-PGA06B

by Minta Medical Limited

Epimed 296-PGA06B is a Class II device made by Minta Medical Limited, cleared under FDA 510(k) K090608 on 14 Jun 2010 and listed in FDA GUDID since 30 Oct 2017 (UDI-DI 05060224333334), 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) K090608

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 Number05060224333334 UDI-DI Date30 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090608 Date14 Jun 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090608 decided 14 Jun 2010 Active
  • FDA GUDID UDI-DI 05060224333334 listed 30 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090608
  2. Listed FDA GUDID 05060224333334

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Epimed
Generic name
Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
Model / Ref / Catalog
296-PGA06B
Primary DI / UDI-DI
05060224333334
510(k) Number
FDA product code
GXI
GMDN term
Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
Device class
Class II
Regulation number
882.4725
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable

Cleared under the same submission (K090608)

and 8 more cleared under K090608

Similar devices

Other devices filed under FDA product code GXI (PROBE, RADIOFREQUENCY LESION).

Other devices from Minta Medical Limited

  • Minta

    Class IIb

  • Epimed 296-PARN

    Class II

  • Epimed 296-DPARN

    Class II

  • Epimed 296-PA06R

    Class II

See all devices from Minta Medical Limited →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)