Cleared Traditional

CANDELA URETHRAL/BLADDER SOUND (K950633) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K950633 · Candela Laser Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
21d
Days
Class 1
Risk

K950633 is an FDA 510(k) clearance for the CANDELA URETHRAL/BLADDER SOUND. Classified as Sound, Urethral, Metal Or Plastic (product code FBX), Class I - General Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5520 - 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 Candela Laser Corp. devices

Submission Details

510(k) Number K950633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date March 06, 1995
Days to Decision 21 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 130d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FBX Sound, Urethral, Metal Or Plastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5520
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.