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510(k) K963950

BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE by Bioderm, Inc. — Product Code EXI

K963950 is an FDA 510(k) premarket notification submitted by Bioderm, Inc. for the device "BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code EXI (Device, Paste-On For Incontinence, Sterile), a Class I device regulated under 21 CFR 876.5250. Bioderm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
October 2, 1996
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 Bioderm, Inc.

  • K990955 — MODIFICATION OF:BIODERM FOAM WOUND DRESSING (May 18, 1999)
  • K982778 — BIODERM FOAM WOUND DRESSING (October 21, 1998)
  • K982939 — BTF THIN FILM WOUND DRESSING (October 13, 1998)
  • K980451 — BIODERM CALCIUM ALGINATE DRESSING (April 9, 1998)
  • K973429 — BIODERM FOAM WOUND DRESSING (December 1, 1997)
  • K963602 — BIODERM PVP FOAM WOUND DRESSING (October 30, 1996)
  • K951166 — BIODERM MEDICAL HYDROGEL ISLAND DRESSING (June 21, 1995)
  • K951842 — BIODERM MEDICAL TRANSPARENT FILM DRESSING (June 12, 1995)
  • K950685 — BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING (June 9, 1995)
  • K950619 — BIODERM MEDICAL FOAM WOUND DRESSING (April 25, 1995)

Other clearances for product code EXI

  • K971499 — FEMALE EXTERNAL URINARY COLLECTION POUCH (August 28, 1997)
  • K970443 — HOLLISTER RETRACTED PENIS POUCH (February 25, 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)
  • K915616 — URIHESIVE STRIP (January 23, 1992)

FDA data resources