Cleared Special

K031527 - MODIFICATION TO CAVERMAP SURGICAL AID

K031527 is an FDA 510(k) clearance for MODIFICATION TO CAVERMAP SURGICAL AID, manufactured by Blue Torch Medical Technologies. The device is a Class 1 Gastroenterology & Urology device with product code FGM cleared through the Special 510(k) pathway after a 21-day FDA review.

K031527 · Blue Torch Medical Technologies · Gastroenterology & Urology device
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Jun 2003
Decision
21d
Days
Class 1
Risk

K031527 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 Blue Torch Medical Technologies (Newton, US). The FDA issued a Cleared decision on June 5, 2003 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 Blue Torch Medical Technologies devices

FDA 510(k) Submission Details - K031527

510(k) Number K031527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2003
Decision Date June 05, 2003
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.

FGM Device Classification - Class 1, General Controls

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.