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510(k) K915616

URIHESIVE STRIP by Convatec, A Division of E.R. Squibb & Sons — Product Code EXI

K915616 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons for the device "URIHESIVE STRIP". The FDA issued a decision of Substantially Equivalent on January 23, 1992. The device falls under product code EXI (Device, Paste-On For Incontinence, Sterile), a Class I device regulated under 21 CFR 876.5250. 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
January 23, 1992
Date Received
December 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Paste-On For Incontinence, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
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 EXI

  • K971499 — FEMALE EXTERNAL URINARY COLLECTION POUCH (August 28, 1997)
  • K970443 — HOLLISTER RETRACTED PENIS POUCH (February 25, 1997)
  • K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (January 10, 1997)
  • K931277 — HOLLISTER PREMIUM URINE COLLECTOR (June 23, 1993)
  • K924755 — CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION (June 22, 1993)
  • K915246 — CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) (February 5, 1992)

FDA data resources