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510(k) K872519

STERILIZED OMNI GEL by Echo Ultrasound — Product Code JOT

K872519 is an FDA 510(k) premarket notification submitted by Echo Ultrasound for the device "STERILIZED OMNI GEL". The FDA issued a decision of Substantially Equivalent on August 3, 1987. The device falls under product code JOT (Electrode, Gel, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Echo Ultrasound has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1987
Date Received
June 25, 1987
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 Echo Ultrasound

  • K924054 — PHONOCARDIOGRAPH (January 22, 1993)
  • K903414 — TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN (September 19, 1990)
  • K893225 — COUPLANT WARMING DEVICE (October 12, 1989)
  • K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS (January 23, 1985)
  • K844034 — SONOCARE (January 23, 1985)

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)
  • K871565 — ULTRASOUND TRANSDUCER GEL, STERILE (July 15, 1987)
  • K800933 — R2 ELECTROSURG. RETURN ELECT. #225ETC. (May 20, 1980)

FDA data resources