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510(k) K904418

ULTRASOUND COUPLING GEL by Geno Laboratories — Product Code JOT

K904418 is an FDA 510(k) premarket notification submitted by Geno Laboratories for the device "ULTRASOUND COUPLING GEL". The FDA issued a decision of Substantially Equivalent on February 11, 1991. The device falls under product code JOT (Electrode, Gel, Electrosurgical), a Class II device regulated under 21 CFR 878.4400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1991
Date Received
September 27, 1990
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 for product code JOT

  • K923647 — RFG-DGP DISPOSABLE GROUNDING PADS (November 9, 1992)
  • K905545 — ULTRASOUND TRANSMISSION GEL (March 29, 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