Home / 510(k) Clearances / K833075

510(k) K833075

WET DRESSING KIT by Clinipad Corp. — Product Code KDD

K833075 is an FDA 510(k) premarket notification submitted by Clinipad Corp. for the device "WET DRESSING KIT". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Clinipad Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1984
Date Received
September 9, 1983
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 Clinipad Corp.

  • K931560 — CARDIAC CATHETERIZATION TRAY (July 11, 1994)
  • K931668 — PICC INSERTION TRAY (March 7, 1994)
  • K932071 — I.V. START KIT (February 17, 1994)
  • K932010 — V.A.D. ACCESS KIT (February 3, 1994)
  • K932036 — LACERATION TRAY (December 13, 1993)
  • K932016 — TRACHEOSTOMY CARE TRAY (November 3, 1993)
  • K862562 — PUNCH BIOPSY KIT (October 7, 1986)
  • K862563 — TRACHEOSTOMY CLEANSING SOLUTION (July 15, 1986)
  • K833432 — CATHETER INSERTION KIT (December 28, 1983)
  • K830476 — OR PREP KIT (March 31, 1983)

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