Cleared Traditional

K903715 - CONDOM SEAL

K903715 is an FDA 510(k) clearance for CONDOM SEAL, manufactured by Mark Sullivan, M.D., P.C.. The device is a Class 1 Gastroenterology & Urology device with product code EXJ cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K903715 · Mark Sullivan, M.D., P.C. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
162d
Days
Class 1
Risk

K903715 is an FDA 510(k) clearance for the CONDOM SEAL. Classified as Device, Incontinence, Urosheath Type, Sterile (product code EXJ), Class I - General Controls.

Submitted by Mark Sullivan, M.D., P.C. (Mission Viejo, US). The FDA issued a Cleared decision on January 23, 1991 after a review of 162 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mark Sullivan, M.D., P.C. devices

FDA 510(k) Submission Details - K903715

510(k) Number K903715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1990
Decision Date January 23, 1991
Days to Decision 162 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 130d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

EXJ Device Classification - Class 1, General Controls

Product Code EXJ Device, Incontinence, Urosheath Type, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXJ Device, Incontinence, Urosheath Type, Sterile

All 10
Devices cleared under the same product code (EXJ) and FDA review panel - the closest regulatory comparables to K903715.
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
K940269 · Hollister, Inc. · Jun 1994
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
K924407 · Coloplast A/S · Sep 1992
SILICONE MALE EXTERNAL CATHETER
K913524 · Mentor Corp. · Oct 1991
CATHETER, DISP., EXTERNAL, MALE
K772144 · Medline Industries, Inc. · Nov 1977