Epimed 296-DPA06R

• FDA 510(k) K090608 decided 14 Jun 2010 Active
• FDA GUDID UDI-DI 05060224334522 listed 30 Oct 2017 Listed

1. 14 Jun 2010 Cleared FDA 510(k) K090608
2. 30 Oct 2017 Listed FDA GUDID 05060224334522

Trade name

Epimed

Generic name

Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

Model / Ref / Catalog

296-DPA06R

Primary DI / UDI-DI

05060224334522

510(k) Number

K090608 ↗

FDA product code

GXI

GMDN term

Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

Device class

Class II

Regulation number

882.4725

GUDID distribution status

In Commercial Distribution

Sterilisation method

Ethylene Oxide

MRI safety

MR Unsafe

Category: Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

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

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• Vesta NLT-150-18-10-CS by Stratus Medical LLC
• SMITH & NEPHEW RF CANNULAE by Smith & Nephew, Inc.
• STORZ DISPOSABLE BIPOLAR PENCILS by Storz Instrument Co.
• RF Cannula by Shanghai Samedical & Plastic Instruments Co., Ltd.
• RADIONICS MICROELECTRODE KIT by Radionics, Inc.
• CN-10 by Boston Scientific Neuromodulation
• TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL by Top Corp.
• VAXIOM FAMILY OF RF LESION PROBES & ELEC by Progress Mankind Technology
• SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE, FLEXIBLE by Radionics, 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-PA06R

  Class II

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

See all devices from Minta Medical Limited →