Epimed 296-DPA06S10

• FDA 510(k) K090608 decided 14 Jun 2010 Active
• FDA GUDID UDI-DI 05060224334508 listed 30 Oct 2017 Listed

1. 14 Jun 2010 Cleared FDA 510(k) K090608
2. 30 Oct 2017 Listed FDA GUDID 05060224334508

Trade name

Epimed

Generic name

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

Model / Ref / Catalog

296-DPA06S10

Primary DI / UDI-DI

05060224334508

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

Size

Length — 100 Millimeter

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

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

• SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE, FLEXIBLE by Radionics, Inc.
• Coolief* Cooled RF Probe by Halyard Health
• PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS by Baylis Medical Co., Inc.
• INTRACEPT Intraosseous Nerve Ablation System by Relievant Medsystems, Inc.
• Vesta NLT-150-20-10-CS by Stratus Medical LLC
• Nimbus NIM-050-10BB by Stratus Medical LLC
• CU-15522 by Boston Scientific Neuromodulation
• RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED by Pajunk GmbH Medizintechnologie
• COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA by Cosman Medical, Inc.
• OneRF Trigeminal Nerve Radiofrequency Probes by NEUROONE MEDICAL TECHNOLOGIES CORP.

• 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 →