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510(k) K810251

SYRINGE, ENT by Megaplast, Inc. — Product Code KYZ

K810251 is an FDA 510(k) premarket notification submitted by Megaplast, Inc. for the device "SYRINGE, ENT". The FDA issued a decision of Substantially Equivalent on March 11, 1981. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Megaplast, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1981
Date Received
January 29, 1981
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 Megaplast, Inc.

  • K822158 — OPEN HEART TRAY (CUSTOM DESIGNED) (October 13, 1982)
  • K821313 — SURGICAL UTILITY DRAPE (June 21, 1982)
  • K820423 — SUTURE REMOVAL TRAY (March 10, 1982)
  • K820136 — URINARY DRAINAGE BAG (January 29, 1982)
  • K810249 — TRAY, CATHERIZATION, URETHRAL (April 7, 1981)
  • K810250 — TRAY, IRRIGATION (April 7, 1981)

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