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510(k) K791168

DEXIDE DISPOSABLE PREP STICK by Dexide, Inc. — Product Code KXF

K791168 is an FDA 510(k) premarket notification submitted by Dexide, Inc. for the device "DEXIDE DISPOSABLE PREP STICK". The FDA issued a decision of Substantially Equivalent on July 30, 1979. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025. Dexide, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
June 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Absorbent Tipped, Non-Sterile
Device Class
Class I
Regulation Number
880.6025
Review Panel
HO
Submission Type

Other clearances by Dexide, Inc.

  • K991814 — MULTACHOICE INSTRUMENTS (June 23, 1999)
  • K990379 — MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES (March 4, 1999)
  • K981940 — MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES (September 25, 1998)
  • K981941 — MULTAPORT CANNULA REDUCER AND ACCESSORIES (July 29, 1998)
  • K953611 — DEXIDE ENDO-LUBE KIT (September 15, 1995)
  • K944509 — DEXIDE INSUFFLATION TUBING WITH FILTER (February 7, 1995)
  • K924117 — DEXIDE LAPAROSCOPIC KITS (March 23, 1993)
  • K923845 — DEXIDE LAPAROSCOPIC ACCESSORIES (November 25, 1992)
  • K921709 — ENDOBAG, MODIFICATION (July 14, 1992)
  • K913762 — MONOSCOPY(TM) BRAND, ENDOBAG (October 28, 1991)

Other clearances for product code KXF

  • K123184 — FINN CHAMBERS AQUA (December 19, 2012)
  • K103409 — ALLERGEAZE R CLEAR (March 15, 2011)
  • K063160 — ALLERGEAZE PATCH TEST CHAMBERS (December 22, 2006)
  • K013820 — FINN CHAMBER (R) (January 30, 2002)
  • K992553 — IQ CHAMBERS (April 12, 2000)
  • K870762 — EAR APPLICATOR, CATALOG NO. 2229 (March 6, 1987)
  • K843720 — COTTON TIPPED APPLICATORS, SINGLE (October 4, 1984)
  • K820962 — COTTON SWABS (April 20, 1982)
  • K813506 — FARRORS TMJ CASSETTE HOLDER (January 29, 1982)
  • K811365 — HILL TOP CHAMBER (August 20, 1981)

FDA data resources