DACOMED EXTERNAL MALE CONTINENCE DEVICE— 510(k) K885323

Name: FDA 510(k) clearance K885323
Creator: U.S. Food and Drug Administration
Published: 1989-02-08

Substantially Equivalent

Dacomed Corp.

FDA 510(k) clearance K885323 for DACOMED EXTERNAL MALE CONTINENCE DEVICE, Substantially Equivalent on 1989-02-08. Applicant: Dacomed Corp.. Device class: 1.

Clearance details

Applicant: Dacomed Corp.
Product code: Code FHA
Device class: Class 1
Regulation: 21 CFR 876.5160
Advisory panel: Gastroenterology, Urology
Date received: 1988-12-28
Decision date: 1989-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHA

view all

K974040 — C3 EXTERNAL MALE BLADDER CONTROL DEVICE1998-07-14
K971992 — UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)1997-08-01
K970308 — MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE1997-04-02
K964580 — CAP-AID (IMPROVED)1997-01-10
K955810 — U-TEX1996-01-24

More clearances from Dacomed Corp.

view all

K953640 — DUNA II PENILE PROSTHESIS1995-10-27
K941781 — RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM1994-08-25
K920409 — DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE1992-05-11
K920420 — DURA II PENILE PROSTHESIS1992-04-16
K912344 — MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS1991-10-11

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