Cleared Special

K010098 - MODIFICATION TO CAVERMAP SURGICAL AID (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K010098 · Uromed Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
21d
Days
Class 1
Risk

K010098 is an FDA 510(k) clearance for the MODIFICATION TO CAVERMAP SURGICAL AID. Classified as Probe And Director, Gastro-urology (product code FGM), Class I - General Controls.

Submitted by Uromed Corp. (Norwood, US). The FDA issued a Cleared decision on February 1, 2001 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 876.4730 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Uromed Corp. devices

Submission Details

510(k) Number K010098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date February 01, 2001
Days to Decision 21 days
Submission Type Special
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
Modification to existing cleared device.

Device Classification

Product Code FGM Probe And Director, Gastro-urology
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.