510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131852Substantially Equivalent

Hc-1 and Hc-1 Classic

Transcendencias Comerciales SL Transcom, San Sebastian, Guipuzcoa, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131852 is the FDA 510(k) clearance record for HC-1 AND HC-1 CLASSIC, a class II device, cleared for Transcendencias Comerciales SL Transcom on under FDA product code KPL (Colonic Irrigation System). FDA records list one 510(k) clearance for Transcendencias Comerciales SL Transcom. As of , FDA records show no recalls naming K131852.

Clearance record

Decision date
Received
(300 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Transcendencias Comerciales SL Transcom C/Zubiberri 31- Planta Baja Local 1, San Sebastian, Guipuzcoa, ES
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPL

Trailing 12 months

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

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