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510(k) K924809

IRRIGATION TRAY W/ BULB SYRINGE by Customed, Inc. — Product Code KYZ

K924809 is an FDA 510(k) premarket notification submitted by Customed, Inc. for the device "IRRIGATION TRAY W/ BULB SYRINGE". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 7, 1993. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Customed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 7, 1993
Date Received
September 24, 1992
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 by Customed, Inc.

  • K260116 — CustoMED Viewer (June 3, 2026)
  • K974647 — FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 (January 5, 1998)
  • K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) (December 4, 1997)
  • K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277 (November 25, 1996)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K962596 — CUSTOMED BLOOD EXTRACTION KIT (September 27, 1996)
  • K961442 — UNIVERSAL DRAINAGE TRAY (May 9, 1996)
  • K953678 — STERIMED STERIZATION WRAPPER (NON-STERILE) (October 2, 1995)
  • K950295 — WOUND CLOSURE/LACERATION TRAY (April 18, 1995)
  • K942177 — FOLEY CATHETERIZATION TRAY (September 8, 1994)

Other clearances for product code KYZ

  • K201877 — OtoSet- Ear Cleaning System (November 5, 2020)
  • 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)

FDA data resources