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510(k) K924117

DEXIDE LAPAROSCOPIC KITS by Dexide, Inc. — Product Code KDD

K924117 is an FDA 510(k) premarket notification submitted by Dexide, Inc. for the device "DEXIDE LAPAROSCOPIC KITS". The FDA issued a decision of Substantially Equivalent (kit) on March 23, 1993. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Dexide, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 23, 1993
Date Received
August 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)
  • K923845 — DEXIDE LAPAROSCOPIC ACCESSORIES (November 25, 1992)
  • K921709 — ENDOBAG, MODIFICATION (July 14, 1992)
  • K913762 — MONOSCOPY(TM) BRAND, ENDOBAG (October 28, 1991)
  • K912637 — LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE (October 4, 1991)

Other clearances for product code KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (August 13, 2001)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)

FDA data resources