Product code KYZ— General Hospital
ZEROWET SPLASHIELD
- Classification name
- Syringe, Irrigating (Non Dental)
- Device class
- Class 1
- Regulation
- 21 CFR 880.6960
- Advisory panel
- General Hospital
- Total cleared
- 41
- First cleared
- Most recent
Market context for product code KYZ
FDA has cleared devices under product code KYZ between 1978 and 2020, filed by 33 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2020
- 2011
- 2009
- 2005
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1991
- 1990
- 1989
- 1988
Top applicants under product code KYZ
Recent clearances under product code KYZ
- K201877 — OtoSet- Ear Cleaning System
- K102563 — SINGLE CANNULA EXTENDED APPLICATOR
- K092022 — TISSU TRANS HARVEST TUBING
- K050797 — TISSU-TRANS
- K991254 — QS DELIVERY SYSTEM
- K982435 — IRRIGATION SYRINGE KIT
- K974288 — ZEROWET SPLASHIELD
- K964833 — RMI DUAL FLUID IRRIGATING SYRINGE
- K960725 — MARPP PRESSURE MONITORING SYSTEM
- K960212 — CPR IRRIGATION TRAY
- K952406 — REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION
- K952407 — REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER
- K933171 — INMAN IRRIGATION TAPERED PROBE
- K940371 — SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP
- K930610 — TALC DISPENSER SYRINGE
- K924517 — AVITENE DISPENSER SYRINGE
- K931912 — IRRIGATING BLUNT DISSECTOR
- K931946 — WELCH ALLYN EARCLEANER
- K924809 — IRRIGATION TRAY W/ BULB SYRINGE
- K905173 — SPLASH GUARD
- K905365 — INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM
- K903759 — IRRICLEAR EAR IRRIGATION SYRINGE
- K900208 — ZEROWET SPLASHIELD
- K902854 — GRAVITY ASSIST
- K896800 — IRRIGATION TRAY
- K894470 — STRYKER TRAUMA TRAY
- K890728 — STERILE IRRIGATION TRAYS
- K884786 — EAR IRRIGATION SET 101 (EARIGATOR)
- K884749 — JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE
- K883506 — IRRIGATION KIT
- K883338 — SURGICAL SEALANT APPLICATOR
- K881020 — SURGICAL SEALANT DISPENSER (SSD)
- K830572 — CLEAN-FLUSH
- K821530 — SYRINGE IRRIGATING
- K813027 — STERILE IRRIGATING SYRINGES, KITS,TRAY
- K810251 — SYRINGE, ENT
- K810209 — IRRIJET
- K803200 — IRRIGATION SET W/BULB SYRINGE
- K801573 — SAPCRILL THERMODETECT BREAST SCANNER DEV
- K791998 — 60CC IRRIGATING SYRINGE, PISTON TYPE,
- K780794 — IRRIGATION CAP
Data sourced from openFDA. This site is unofficial and independent of the FDA.