Home / 510(k) Clearances / K800933

510(k) K800933

R2 ELECTROSURG. RETURN ELECT. #225ETC. by R2 Corp. — Product Code JOT

K800933 is an FDA 510(k) premarket notification submitted by R2 Corp. for the device "R2 ELECTROSURG. RETURN ELECT. #225ETC.". The FDA issued a decision of Substantially Equivalent on May 20, 1980. The device falls under product code JOT (Electrode, Gel, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. R2 Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1980
Date Received
April 21, 1980
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 R2 Corp.

  • K832516 — MAGNATRODE CARDIAC MONITORING ELECTRODE (December 16, 1983)
  • K800936 — R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 (May 23, 1980)
  • K800931 — R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 (May 23, 1980)
  • K800930 — R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. (May 23, 1980)
  • K800935 — R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) (May 23, 1980)
  • K800937 — R2 PLATE TYPE CABLE-ADAPTOR #S 175,176 (May 23, 1980)
  • K800932 — ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 (May 23, 1980)
  • K800934 — R2 ESU CABLE-ADAPTER MODELS 160,161 (May 20, 1980)

Other clearances for product code JOT

  • K923647 — RFG-DGP DISPOSABLE GROUNDING PADS (November 9, 1992)
  • 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)

FDA data resources