510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252592Substantially Equivalent

TELLTALE Electrosurgical Guidewire System

Telltale, LLC, Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252592 is the FDA 510(k) clearance record for TELLTALE Electrosurgical Guidewire System, a class II device, cleared for Telltale, LLC on under FDA product code SGO (Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures). FDA's definition for product code SGO reads: "The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure". FDA records list one 510(k) clearance for Telltale, LLC. As of , FDA records show no recalls naming K252592.

Clearance record

Decision date
Received
(90 days to decision)
Product code
SGO Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Regulation
21 CFR 870.1254
Device class
Class II
Review panel
Cardiovascular
Applicant
Telltale, LLC 4 Dundee Park Dr., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SGO

Trailing 12 months
1 clearance under product code SGO in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGO, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260