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510(k) K923647

RFG-DGP DISPOSABLE GROUNDING PADS by Radionics, Inc. — Product Code JOT

K923647 is an FDA 510(k) premarket notification submitted by Radionics, Inc. for the device "RFG-DGP DISPOSABLE GROUNDING PADS". The FDA issued a decision of Substantially Equivalent on November 9, 1992. The device falls under product code JOT (Electrode, Gel, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Radionics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1992
Date Received
July 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Gel, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Radionics, Inc.

  • K030697 — RADIONICS SINGLE USE GROUND PAD (DGP-HP) (April 4, 2003)
  • K002773 — NEUROMAP WITH NEURO 100 (October 23, 2000)
  • K001741 — RADIONICS RF DISC CATHETER ELECTRODE SYSTEM (October 23, 2000)
  • K992226 — XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (August 4, 2000)
  • K001950 — OPTICAL TRACKING SYSTEM (OTS) (July 26, 2000)
  • K001700 — XPLAN 2.1 (June 28, 2000)
  • K001431 — MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (May 17, 2000)
  • K000057 — RADIONICS LUMBOPERITONEAL SHUNT (March 20, 2000)
  • K993594 — CONFORMAX MMLC VR1 (December 15, 1999)
  • K991399 — RADIONICS MICROELECTRODE KIT (September 21, 1999)

Other clearances for product code JOT

  • K905545 — ULTRASOUND TRANSMISSION GEL (March 29, 1991)
  • K904418 — ULTRASOUND COUPLING GEL (February 11, 1991)
  • K901217 — TRIA-SONIC ULTRA SOUND TRANSMISSION GEL (June 22, 1990)
  • K894490 — STERILE ULTRASOUND TRANSMISSION GEL (October 5, 1989)
  • K884503 — ULTRASONIC TRANSMISSION GEL (February 13, 1989)
  • K872519 — STERILIZED OMNI GEL (August 3, 1987)
  • K871565 — ULTRASOUND TRANSDUCER GEL, STERILE (July 15, 1987)
  • K800933 — R2 ELECTROSURG. RETURN ELECT. #225ETC. (May 20, 1980)

FDA data resources