Home / 510(k) Clearances / K902854

510(k) K902854

GRAVITY ASSIST by Instrument Makar, Inc. — Product Code KYZ

K902854 is an FDA 510(k) premarket notification submitted by Instrument Makar, Inc. for the device "GRAVITY ASSIST". The FDA issued a decision of Substantially Equivalent on August 29, 1990. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Instrument Makar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1990
Date Received
June 29, 1990
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 Instrument Makar, Inc.

  • K002600 — LITWIN CRUICATE ANCHOR (November 15, 2000)
  • K980999 — ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT (November 6, 1998)
  • K963396 — BIOSPHERE SUTURE ANCHOR (May 6, 1997)
  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH (November 19, 1996)
  • K960555 — BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR (July 9, 1996)
  • K943249 — BIOABSORBABLE INTERFERENCE SCREW (July 31, 1995)
  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • K942828 — MAKAR FULL AND HALF FACE SHIELD (February 23, 1995)
  • K930980 — INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW (February 10, 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