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510(k) K201877

OtoSet- Ear Cleaning System by Safkan, Inc. — Product Code KYZ

K201877 is an FDA 510(k) premarket notification submitted by Safkan, Inc. for the device "OtoSet- Ear Cleaning System". The FDA issued a decision of Substantially Equivalent on November 5, 2020. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2020
Date Received
July 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Non Dental)
Device Class
Class I
Regulation Number
880.6960
Review Panel
HO
Submission Type

Other clearances for product code KYZ

  • K102563 — SINGLE CANNULA EXTENDED APPLICATOR (March 15, 2011)
  • K092022 — TISSU TRANS HARVEST TUBING (August 17, 2009)
  • K050797 — TISSU-TRANS (July 13, 2005)
  • K991254 — QS DELIVERY SYSTEM (August 23, 1999)
  • K982435 — IRRIGATION SYRINGE KIT (November 6, 1998)
  • K974288 — ZEROWET SPLASHIELD (January 29, 1998)
  • K964833 — RMI DUAL FLUID IRRIGATING SYRINGE (February 19, 1997)
  • K960725 — MARPP PRESSURE MONITORING SYSTEM (July 15, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)
  • K952407 — REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER (August 7, 1995)

FDA data resources