Safeseal Reusable Urinal System

FDA 510(k) K851682 · Dbt Medical , Ltd.

Substantially Equivalent

510(k) numberK851682

Submission

Device name
Safeseal Reusable Urinal System
Applicant
Dbt Medical , Ltd.
Witney,0x8 7az, GB
Received
April 23, 1985
Decision date
June 24, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EXJ – Device, Incontinence, Urosheath Type, Sterile
Device class
Class I (low risk)
Regulation
21 CFR 876.5250
Specialty
Gastroenterology, Urology

Other 510(k)s with product code EXJ

510(k)DeviceApplicantDecision
K970465Bouser's UrinalEXJ · Traditional General Polymers12/18/1997SE
K972100Vented External Male Urinary Catheter(Vented Cath 5000)EXJ · Traditional Advanced Care Medical Products07/31/1997SE
K970966Comfort Cath Choice Male External CatheterEXJ · Traditional Sierra Laboratories, Inc.04/22/1997SE
K963265Prosys Samec laEXJ · Traditional Convatec, A Division of E.R. Squibb & Sons10/25/1996SE
K962900Self Retaining Male External Urinary CatheterEXJ · Traditional Hollister, Inc.09/16/1996SE
K962413Comfort Cath Special Self Adhering Male External CatheterEXJ · Traditional Sierra Laboratories, Inc.07/15/1996SE
K962384Comfort Sheath Reusable Male External CatheterEXJ · Traditional Sierra Laboratories, Inc.07/15/1996SE
K952082Rochester Medical Corporation Silicone Male External CatheterEXJ · Traditional Rochester Medical Corp.07/18/1995SE
K945628Clear Advantage IIEXJ · Traditional Mentor Corp.07/06/1995SE
K951530Prosys Urihesive System laEXJ · Traditional Convatec, A Division of E.R. Squibb & Sons05/12/1995SE

More from Convatec, A Division of E.R. Squibb & Sons

510(k)DeviceDecision
K851681Safestretch Incontinence SystemKNX · Traditional 06/28/1985SE
K851680Ostomy Bags IleostomyEXB · Traditional 06/27/1985SE
K851679Ostomy Bags ColostomyEXB · Traditional 06/27/1985SE
K851678Ostomy Bags UretherostomyEXB · Traditional 06/27/1985SE

Questions and answers

When was Safeseal Reusable Urinal System cleared by the FDA?

Safeseal Reusable Urinal System (K851682) received a 510(k) decision of Substantially Equivalent on June 24, 1985, 62 days after the submission was received.

What is the product code of K851682?

The FDA product code is EXJ – Device, Incontinence, Urosheath Type, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.