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510(k) K871565

ULTRASOUND TRANSDUCER GEL, STERILE by Amedic USA — Product Code JOT

K871565 is an FDA 510(k) premarket notification submitted by Amedic USA for the device "ULTRASOUND TRANSDUCER GEL, STERILE". The FDA issued a decision of Substantially Equivalent on July 15, 1987. The device falls under product code JOT (Electrode, Gel, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Amedic USA has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1987
Date Received
April 22, 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 Amedic USA

  • K897120 — EQUIP COVERS, STERILE (January 4, 1990)
  • K892070 — GENERAL IVT NEEDLE GUIDE KIT, STERILE (September 5, 1989)
  • K892071 — GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE (August 8, 1989)
  • K892069 — EXTENDED COVERS, STERILE (August 8, 1989)
  • K892068 — TRT (ACUSON) NEEDLE GUIDE KIT, STERILE (August 4, 1989)
  • K871467 — BIOPSY NEEDLE GUIDE KIT, STERILE (August 21, 1987)
  • K871609 — ULTRASOUND TRANSDUCER SHEATHS, STERILE (July 15, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K864219 — TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE (March 27, 1987)

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)
  • K800933 — R2 ELECTROSURG. RETURN ELECT. #225ETC. (May 20, 1980)

FDA data resources