Condom Seal

FDA 510(k) K903715 · Mark Sullivan, M.D., P.C.

Substantially Equivalent

510(k) numberK903715

Submission

Device name
Condom Seal
Applicant
Mark Sullivan, M.D., P.C.
Mission Viejo, CA, US
Received
August 14, 1990
Decision date
January 23, 1991
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

Questions and answers

When was Condom Seal cleared by the FDA?

Condom Seal (K903715) received a 510(k) decision of Substantially Equivalent on January 23, 1991, 162 days after the submission was received.

What is the product code of K903715?

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