510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862424Substantially Equivalent

Steerable Catheter System

Endovations, Camp Hill PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862424 is the FDA 510(k) clearance record for STEERABLE CATHETER SYSTEM, a class II device, cleared for Endovations on under FDA product code GCP (Endoscope, Ac-Powered And Accessories). FDA records list 38 510(k) clearances for Endovations, from to . As of , FDA records show no recalls naming K862424.

Clearance record

Decision date
Received
(88 days to decision)
Product code
GCP Endoscope, Ac-Powered And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endovations 895 Poplar Church Rd., Camp Hill PA
Third party review
No

Clearances, product code GCP

Trailing 12 months

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

FDA records show no clearances under product code GCP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCP, 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