510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240246Substantially Equivalent

Accusafe Transseptal Guidewire (GTR31180, GTR31230)

Synaptic Medical Corporation, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240246 is the FDA 510(k) clearance record for Accusafe Transseptal Guidewire (GTR31180, GTR31230), a class II device, cleared for Synaptic Medical Corporation on under FDA product code DRC (Trocar). FDA records list 7 510(k) clearances for Synaptic Medical Corporation, from to . As of , FDA records show no recalls naming K240246.

Clearance record

Decision date
Received
(178 days to decision)
Product code
DRC Trocar
Regulation
21 CFR 870.1390
Device class
Class II
Review panel
Cardiovascular
Applicant
Synaptic Medical Corporation 1959 Kellogg Ave., Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRC

Trailing 12 months

FDA records hold no clearances under product code DRC in the trailing twelve months.

FDA records show no clearances under product code DRC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260