Home / 510(k) Clearances / K924517

510(k) K924517

AVITENE DISPENSER SYRINGE by Nusurg, Inc. — Product Code KYZ

K924517 is an FDA 510(k) premarket notification submitted by Nusurg, Inc. for the device "AVITENE DISPENSER SYRINGE". The FDA issued a decision of Substantially Equivalent on October 27, 1993. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Nusurg, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1993
Date Received
September 4, 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 Nusurg, Inc.

  • K924792 — MULTIPLE PURPOSE FORCEPS (April 28, 1994)
  • K930610 — TALC DISPENSER SYRINGE (November 4, 1993)
  • K924372 — LAPAROSCOPIC NERVE HOOK (July 30, 1993)
  • K924196 — LAPAROSCOPIC NEEDLE HOLDER (June 25, 1993)

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