Cleared Traditional

K240246 - Accusafe Transseptal Guidewire (GTR31180

K240246 is an FDA 510(k) clearance for Accusafe Transseptal Guidewire (GTR31180, manufactured by Synaptic Medical Corporation. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K240246 · Synaptic Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
178d
Days
Class 2
Risk

K240246 is an FDA 510(k) clearance for the Accusafe Transseptal Guidewire (GTR31180, GTR31230). Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Synaptic Medical Corporation (Carlsbad, US). The FDA issued a Cleared decision on July 26, 2024 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Synaptic Medical Corporation devices

FDA 510(k) Submission Details - K240246

510(k) Number K240246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2024
Decision Date July 26, 2024
Days to Decision 178 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRC Trocar

All 34
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K240246.
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