BCI-100 FECAL INCONTINENCE SYSTEM— 510(k) K904646

Name: FDA 510(k) clearance K904646
Creator: U.S. Food and Drug Administration
Published: 1991-03-19

Substantially Equivalent

Biocare Intl.

FDA 510(k) clearance K904646 for BCI-100 FECAL INCONTINENCE SYSTEM, Substantially Equivalent on 1991-03-19. Applicant: Biocare Intl.. Device class: 2.

Clearance details

Applicant: Biocare Intl.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1990-10-11
Decision date: 1991-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wantagh, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAP

view all

K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE2012-12-13
K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE1998-02-19
K963330 — URODYNAMIC ANALYSIS MODULE1997-04-03
K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER1996-08-27
K931175 — SCHUSTER DISPOSABLE BALLOON PROBE1994-04-01

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