510(k) K951021

CIRCULON SYSTEM STEP 2 by Convatec, A Division of E.R. Squibb & Sons — Product Code MCY

Clearance Details

Decision: SESK (Substantially Equivalent (kit))
Decision Date: June 12, 1995
Date Received: March 7, 1995
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Wound Dressing Kit
Device Class: Class II
Regulation Number: 880.5075
Review Panel: SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Convatec, A Division of E.R. Squibb & Sons

K090254 — SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) (September 4, 2009)
K080383 — AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (May 2, 2008)
K063271 — AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED AN (April 16, 2007)
K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING (June 21, 2002)
K990964 — SIGNADRESS DUODERM DRESSING (May 18, 1999)
K984388 — HA ABSORBENT WOUND DRESSING (March 3, 1999)
K980720 — NONWOVEN PAD (April 15, 1998)
K980382 — NON-WOVEN COMPRESS (March 9, 1998)
K974823 — NONWOVEN DRESSING (February 20, 1998)
K974205 — KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON (February 6, 1998)

Other clearances for product code MCY

K970721 — DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM (March 21, 1997)
K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (November 27, 1996)
K960585 — WOUND CARE COMPRESSION SYSTEM (WCCS) (April 26, 1996)
K952334 — DRESSING CHANGE TRAY (July 14, 1995)
K951022 — CIRCULON SYSTEM STEP 1 (June 12, 1995)
K951476 — E-PACK PROCEDURE KITS (May 23, 1995)
K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
K924690 — VARIOUS NON-STERILE CUSTOM TRAYS/KITS (July 16, 1993)
K923905 — WOUND DRESSING KIT (July 2, 1993)
K926063 — PER-Q-CATH DRESSING CHANGE TRAY (June 7, 1993)