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510(k) K011514

INSTRUMENTS FOR ONE TIME USE - DISPOSABLE by Kencap , Ltd. — Product Code KDD

K011514 is an FDA 510(k) premarket notification submitted by Kencap , Ltd. for the device "INSTRUMENTS FOR ONE TIME USE - DISPOSABLE". The FDA issued a decision of Substantially Equivalent on August 13, 2001. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2001
Date Received
May 17, 2001
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 for product code KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • 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)
  • K924117 — DEXIDE LAPAROSCOPIC KITS (March 23, 1993)

FDA data resources