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510(k) K023722

SAFETYWAND DISPOSABLE HANDPIECE by Spintech, Inc. — Product Code EJI

K023722 is an FDA 510(k) premarket notification submitted by Spintech, Inc. for the device "SAFETYWAND DISPOSABLE HANDPIECE". The FDA issued a decision of Substantially Equivalent on September 2, 2003. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Spintech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2003
Date Received
November 5, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type

Other clearances by Spintech, Inc.

  • K223079 — Stage (October 28, 2022)
  • K212109 — Spin Care Disposable Protective Mask Level 3 (November 14, 2021)
  • K210843 — STAGE (June 29, 2021)
  • K201624 — Spin Care Disposable Protective Mask (March 18, 2021)
  • K173224 — SPIN-SWI (February 23, 2018)
  • K010692 — THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM (June 29, 2001)
  • K992404 — THE WAND (June 6, 2000)
  • K992819 — WAND PLUS (May 11, 2000)
  • K961648 — THE WAND (July 5, 1996)
  • K955654 — SHORTSTOP DISPOSABLE PROPHY ANGLE (February 8, 1996)

Other clearances for product code EJI

  • K171254 — LeEject 2 Dental Syringe and Needle System (November 16, 2017)
  • K142414 — Miltex N-Tralig Intraligamentary Syringe (October 30, 2014)
  • K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE (November 6, 2012)
  • K113247 — ANESTHESIA INJECTION TOOL SET (March 27, 2012)
  • K082249 — MORPHEUS (December 31, 2009)
  • K092943 — ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE (December 11, 2009)
  • K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRAT (March 9, 2009)
  • K081694 — DENJECTOR (September 12, 2008)
  • K061904 — COMPUDENT STA (August 8, 2006)
  • K043322 — MIRAMATIC SAFE SYRINGE SYSTEM (July 21, 2005)

FDA data resources