Epimed 296-PA06S10

• FDA 510(k) K090608 decided 14 Jun 2010 Active
• FDA GUDID UDI-DI 05060224333303 listed 30 Oct 2017 Listed

1. 14 Jun 2010 Cleared FDA 510(k) K090608
2. 30 Oct 2017 Listed FDA GUDID 05060224333303

Trade name

Epimed

Generic name

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

Model / Ref / Catalog

296-PA06S10

Primary DI / UDI-DI

05060224333303

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

Size

Length — 10 Centimeter

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

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

• TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC by Top Corp.
• BMC RF CANNULA by Baylis Medical Co., Inc.
• CP-10 by Boston Scientific Neuromodulation
• OWL RF PROBES by Diros Technology, Inc.
• SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE by Smith & Nephew, Inc.
• INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set by Relievant Medsystems, Inc.
• NEUROTHERM, MODEL JK4 by Eurolink, LLC
• STRYKER RF ELECTRODES AND CANNULAE by Stryker Instruments
• RCE-E661519 by Boston Scientific Neuromodulation
• DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 by Advanced Surgical Products, 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 →