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510(k) K901217

TRIA-SONIC ULTRA SOUND TRANSMISSION GEL by H & P Industries, Inc. — Product Code JOT

K901217 is an FDA 510(k) premarket notification submitted by H & P Industries, Inc. for the device "TRIA-SONIC ULTRA SOUND TRANSMISSION GEL". The FDA issued a decision of Substantially Equivalent on June 22, 1990. The device falls under product code JOT (Electrode, Gel, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. H & P Industries, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1990
Date Received
March 13, 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 by H & P Industries, Inc.

  • K871169 — LUBRICATING JELLY (April 1, 1987)
  • K860961 — GAMMA RADIATION STERILIZED ALCOHOL PREP PADS (April 9, 1986)
  • K830394 — PROVIDONE-IODINE PREP-PADS & TOWELETTES (April 6, 1983)
  • K830393 — PROVIDONE-IODINE SWABSTICKS (April 6, 1983)

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)
  • 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