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510(k) K101952

KONIX ULTRASOUND GEL by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2011
Date Received
July 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa

  • K140506 — JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL (April 17, 2015)
  • K130581 — KONIX STERILE GEL (June 18, 2014)

Other clearances for product code ITX

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  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
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  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)