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510(k) K143177

KleenGel Dispenser by Kleengel, LLC — Product Code KYX

K143177 is an FDA 510(k) premarket notification submitted by Kleengel, LLC for the device "KleenGel Dispenser". The FDA issued a decision of Substantially Equivalent on September 14, 2015. The device falls under product code KYX (Dispenser, Liquid Medication), a Class I device regulated under 21 CFR 880.6430.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2015
Date Received
November 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dispenser, Liquid Medication
Device Class
Class I
Regulation Number
880.6430
Review Panel
HO
Submission Type

Other clearances for product code KYX

  • K980109 — CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER (August 18, 1998)
  • K954181 — CANYONS BI-DIRECTIONAL CHECK VALVE (November 29, 1995)
  • K830571 — BOTTLE ADAPTER (March 24, 1983)
  • K801008 — MULTI-AD FLUID DISPENSING PUMP MP-3000 (June 2, 1980)
  • K800362 — FLUID DISPENSING SYSTEM (March 12, 1980)
  • K800437 — SYRINGE TIP CONNECTOR (March 12, 1980)
  • K792227 — MULTI-AD FLUID DISPENSING SYSTEM (December 20, 1979)
  • K781364 — PINT BOTTLE WELL (October 17, 1978)
  • K771539 — STEPPER (October 7, 1977)
  • K760517 — CUP, DISPOSABLE MEDICINE (November 12, 1976)

FDA data resources