Epimed 296-PA06R

• FDA 510(k) K090608 decided 14 Jun 2010 Active
• FDA GUDID UDI-DI 05060224333259 listed 30 Oct 2017 Listed

1. 14 Jun 2010 Cleared FDA 510(k) K090608
2. 30 Oct 2017 Listed FDA GUDID 05060224333259

Trade name

Epimed

Generic name

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

Model / Ref / Catalog

296-PA06R

Primary DI / UDI-DI

05060224333259

510(k) Number

K090608 ↗

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

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

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

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• Nimbus NIM-150-10BB by Stratus Medical LLC
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• Vesta NLT-100-22-05-BB by Stratus Medical LLC
• NA DAC-NT by ST. JUDE MEDICAL, INC.

• Minta

  Class IIb

  CE/MDR

• Epimed 296-PARN

  Class II

  FDA 510(k) K090608 Active Cleared 14 Jun 2010 GUDID on market

• Epimed 296-DPARN

  Class II

  FDA 510(k) K090608 Active Cleared 14 Jun 2010 GUDID on market

• Epimed 296-PA06S10

  Class II

  FDA 510(k) K090608 Active Cleared 14 Jun 2010 GUDID on market

See all devices from Minta Medical Limited →