510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K102801Substantially Equivalent

Phtip Disposable Isfet Catheter

E-Cath Co., Ltd., Golden CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102801 is the FDA 510(k) clearance record for PHTIP DISPOSABLE ISFET CATHETER, a class II device, cleared for E-Cath Co., Ltd. on under FDA product code FFX (System, Gastrointestinal Motility (Electrical)). FDA records list one 510(k) clearance for E-Cath Co., Ltd. As of , FDA records show no recalls naming K102801.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FFX System, Gastrointestinal Motility (Electrical)
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
E-Cath Co., Ltd. 13605 W. 7th Ave., Golden CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FFX

Trailing 12 months
2 clearances under product code FFX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FFX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260