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510(k) K830524

HENKE JECT PRESSURE SYRINGE by Smith & Nephew, Mpl Division — Product Code EJI

K830524 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Mpl Division for the device "HENKE JECT PRESSURE SYRINGE". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Smith & Nephew, Mpl Division has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
February 17, 1983
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 Smith & Nephew, Mpl Division

  • K843314 — MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE (September 27, 1984)
  • K841280 — SOLOPAK BRAND FILTER NEEDLE W/5 MICRO (May 21, 1984)
  • K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (April 5, 1984)
  • K833304 — HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST (March 30, 1984)
  • K832126 — MICRO Z DISPOS. SPINAL ANESTH. NEEDLE (August 12, 1983)
  • K831765 — HERAPIN LOCK FLUSH SOLUTION USE KIT (July 12, 1983)
  • K830242 — MICRO 2 HYPODERMIC NEEDLES (February 15, 1983)
  • K761206 — INTEROSSEOUS NEEDLE (December 13, 1976)

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