Cleared Traditional

K950267 - URETHRAL SUTURE GUIDE

K950267 is an FDA 510(k) clearance for URETHRAL SUTURE GUIDE, manufactured by Applied Medical Resources. The device is a Class 1 Gastroenterology & Urology device with product code KOA cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K950267 · Applied Medical Resources · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
8d
Days
Class 1
Risk

K950267 is an FDA 510(k) clearance for the URETHRAL SUTURE GUIDE. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on January 31, 1995 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Medical Resources devices

FDA 510(k) Submission Details - K950267

510(k) Number K950267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1995
Decision Date January 31, 1995
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 130d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

KOA Device Classification - Class 1, General Controls

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
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 - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 25
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K950267.
FiXcision
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VAS DILATOR
K922192 · Cook Urological, Inc. · Aug 1992
GRASPING FORCEPS
K896058 · Annex Medical, Inc. · Dec 1989
MICROSURGICAL CYSTOTOME
K890218 · Kinetic Medical Products · Jan 1989