Home / 510(k) Clearances / K924976

510(k) K924976

ALLKARE(TM) ADHESIVE REMOVER WIPE by Convatec, A Division of E.R. Squibb & Sons — Product Code KOX

K924976 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons for the device "ALLKARE(TM) ADHESIVE REMOVER WIPE". The FDA issued a decision of Substantially Equivalent on April 20, 1993. The device falls under product code KOX (Solvent, Adhesive Tape), a Class I device regulated under 21 CFR 878.4730. Convatec, A Division of E.R. Squibb & Sons has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
October 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solvent, Adhesive Tape
Device Class
Class I
Regulation Number
878.4730
Review Panel
SU
Submission Type

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 KOX

  • K934790 — SEPP ADHESIVE REMOVER (March 11, 1994)
  • K931933 — CHAD LABS ADHESIVE BANDAGE REMOVER (July 8, 1993)
  • K924571 — MEDI-SOL (April 6, 1993)
  • K925618 — 3M REMOVER LOTION PRODUCT NUMBER 86XX (March 31, 1993)
  • K923351 — SKIN SUPPORT PREP PAD (September 14, 1992)
  • K915150 — REMOVE ADHESIVE REMOVER (January 9, 1992)
  • K902009 — ELANTEC'S SURGICAL TAPE REMOVER (August 29, 1990)
  • K895293 — KEMI LABS - ADHESIVE BANDAGE REMOVER (February 9, 1990)
  • K893603 — REMOVE ADHESIVE REMOVER (July 14, 1989)
  • K881359 — DECALCIFYING SOLUTION II (April 19, 1988)

FDA data resources