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510(k) K902441

DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) by Currie Medical Specialties, Inc. — Product Code KDD

K902441 is an FDA 510(k) premarket notification submitted by Currie Medical Specialties, Inc. for the device "DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS)". The FDA issued a decision of Substantially Equivalent (kit, denovo) on August 23, 1990. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Currie Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
August 23, 1990
Date Received
June 1, 1990
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 Currie Medical Specialties, Inc.

  • K151158 — ALP VasQcare Take Home System (December 10, 2015)
  • K143317 — Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) (January 20, 2015)
  • K140092 — CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) (April 16, 2014)
  • K112311 — ALP 501 RB PUMP SYSTEM (September 1, 2011)
  • K874760 — CK 4900 SERIES, GOWN AND TOWEL PAK (December 10, 1987)
  • K872395 — CK 1600 SERIES, TOWELS (July 2, 1987)
  • K871737 — CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR (June 22, 1987)
  • K864816 — CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE (January 8, 1987)
  • K864697 — CK 6000 SERIES, TOWELS (December 18, 1986)
  • K834558 — CK10000 SERIES POUCH & BAGS ETC. (September 5, 1984)

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