BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE— 510(k) K963950

Name: FDA 510(k) clearance K963950
Creator: U.S. Food and Drug Administration
Published: 1997-01-10

Substantially Equivalent

Bioderm, Inc.

FDA 510(k) clearance K963950 for BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE, Substantially Equivalent on 1997-01-10. Applicant: Bioderm, Inc.. Device class: 1.

Clearance details

Applicant: Bioderm, Inc.
Product code: Code EXI
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1996-10-02
Decision date: 1997-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Burnswick, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXI

view all

K971499 — FEMALE EXTERNAL URINARY COLLECTION POUCH1997-08-28
K970443 — HOLLISTER RETRACTED PENIS POUCH1997-02-25
K931277 — HOLLISTER PREMIUM URINE COLLECTOR1993-06-23
K924755 — CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION1993-06-22
K915246 — CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)1992-02-05

More clearances from Bioderm, Inc.

view all

K990955 — MODIFICATION OF:BIODERM FOAM WOUND DRESSING1999-05-18
K982778 — BIODERM FOAM WOUND DRESSING1998-10-21
K982939 — BTF THIN FILM WOUND DRESSING1998-10-13
K980451 — BIODERM CALCIUM ALGINATE DRESSING1998-04-09
K973429 — BIODERM FOAM WOUND DRESSING1997-12-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.