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510(k) K972285

GETTIG STYRL-JECT DELIVERY SYSTEM by Gettig Pharmaceutical Instrument Co. — Product Code EJI

K972285 is an FDA 510(k) premarket notification submitted by Gettig Pharmaceutical Instrument Co. for the device "GETTIG STYRL-JECT DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 11, 1997. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Gettig Pharmaceutical Instrument Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1997
Date Received
June 19, 1997
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 Gettig Pharmaceutical Instrument Co.

  • K041232 — GETTIG UNIVERSAL VIAL ACCESS PIN (July 22, 2004)
  • K033409 — AMERSHAM HEALTH NEEDLE-GUARD (January 21, 2004)
  • K022495 — GETTIG DISPOSABLE SYRINGES (October 8, 2002)
  • K000455 — GETTIG GUARD (April 19, 2000)

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